BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 6088128 · Received November 8, 2016

    Report

    Report Number
    3032391-2016-00010
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    HWQ
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDLINE RENEWAL RECEIVED A REPORT THAT TIPS OF MULTIPLE REPROCESSED SUTURE NEEDLES DETACHED DURING THE COURSE OF USE. NO ADDITIONAL INFORMATION SURROUNDING THE REPORTED INCIDENT(S) IS AVAILABLE AT THIS TIME, AND MEDLINE RENEWAL DID NOT RECEIVE ANY COMMUNICATION FROM THE FACILITY AT THE TIME OF THE REPORTED INCIDENTS. THEREFORE MEDLINE RENEWAL IS UNABLE TO CONFIRM IF THE FAILED DEVICES WERE REPROCESSED, AND/OR IF THEY WERE REPROCESSED BY MEDLINE RENEWAL. THE FAILED DEVICE(S) MODEL NUMBERS, LOT NUMBERS, AND SHIPPING INFORMATION WERE NOT RECEIVED, THEREFORE NO ADDITIONAL MANUFACTURING REVIEW OR PROCESS RECORD REVIEWS COULD BE CONDUCTED. HOWEVER, IN AN ABUNDANCE OF CAUTION MEDLINE RENEWAL IS FILING THIS MEDWATCH FORM. (B)(4) DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    MEDLINE RENEWAL RECEIVED A REPORT THAT TIPS OF MULTIPLE REPROCESSED SUTURE NEEDLES DETACHED DURING THE COURSE OF USE. NO ADDITIONAL INFORMATION SURROUNDING THE REPORTED INCIDENT(S) IS AVAILABLE AT THIS TIME, AND MEDLINE RENEWAL DID NOT RECEIVE ANY COMMUNICATION FROM THE FACILITY AT THE TIME OF THE REPORTED INCIDENTS. THEREFORE MEDLINE RENEWAL IS UNABLE TO CONFIRM IF THE FAILED DEVICES WERE REPROCESSED, AND/OR IF THEY WERE REPROCESSED BY MEDLINE RENEWAL. HOWEVER, IN AN ABUNDANCE OF CAUTION MEDLINE RENEWAL IS FILING THIS MEDWATCH FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738239 UNKNOWN SUTURE PASSER HWQ MEDLINE RENEWAL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention