View Cart / Checkout » 0 items - £0.00
365 Healthcare

Complaints Form

This form can be download here » Customer Complaint Form

Bunzl Healthcare Medical Device Report Form

Fields marked * are mandatory for a successful investigation

 

BHC Complaint Ref:

Internal Use Only

 

*Name of Reporter:

Sales Representative:

*Date form completed:

*Contact method: Email:Telephone:

Customer complaint reference (if applicable):

 

Customer / Complainant Details
Institute / Hospital / Clinic / Company Contact Person / Complainant

*Name of above:

*Contact Name:

*Department:

*Email:

*Address:

*Phone:

Fax:

Complaint Source:

Bunzl HealthcareEmployeeDistributor CustomerEnd UserMHRA

If end user, please provide Job Title:

 

Product information

*Product Code:

*Product Description (include pack size):

*Lot / Batch:

Pharmaceutical Form:

Strength:

Expiry Date:

Number of identical events with the same Lot/Batch Number: Unknown OR  If known please specify number: 

*Is the sample available?

NoYes, not contaminatedYes, contaminatedPhoto evidence only

Defective Quantity to return: 

Customer PO Number:

Date Returned:         Internal use only

** WE REQUIRE A COMPLETED DECONTAMINATION CERTIFICATE BEFORE AUTHORISING THE RETURN OF USED SAMPLES **

 

Event Description 

Procedure name:

Procedure / Date:

Procedure Outcome:

Reason:

Time of event:

UnpackingPreparationIntroductionDuring ProcedureWithdrawalProcedure ClosurePost ProcedureNo information available
*Did the event lead to complications for the user or patient which required medical intervention?*1 NoYes
If Yes,    UserPatient

*If Yes, please provide details of methods of medical intervention required:

Competent Authority Notified?*2 NoYes
If Yes Reported By: CustomerBunzl Healthcare

Date reported:

Competent Authority Reference:
Labour Standards Concern? YesNo

If the answers to 1 and 2 are yes and no, this complaint will be treated with priority and the TQRM will be consulted to decide if the competent authority needs to be notified.

 

 

BHC USE ONLY ASSESSMENT CRITERIA FOR REPORTABLE INCIDENTS FOR OWN BRAND PRODUCTS ONLY
Did the event lead to the deterioration of health or death to a patient, user or other person? NoYes
Did the event cause an unanticipated adverse reaction or side effect to a patient, user or other person? NoYes
Was a wrong diagnosis received to due to a faulty medical device? NoYes
Did the event occur due to an inaccuracy of the products labelling or IFU? NoYes
Did the event occur due to unanticipated interaction(s) with other substances or products? NoYes
Did the event cause inappropriate therapy? NoYes
If any of the above answer yes, send to the TQRM for final assessment.

Assessment Outcome

Assessment carried out by:

Non Reportable Incident NoYes

Reportable Incident NoYes

Competent Authority Reference

 

Upon submission a copy of this form will be sent back to you, please ensure your email is correct.
If you do not receive an email within 24 Hrs please call the Complaints Department on (+44) 01905 778365.

 

Prices shown are excluding Tax (VAT). For International Orders Please Call: +44 1905 778365 Dismiss