BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURG PAT XRAY 1/2X1 1/2

    MDR report key: 12662317 · Received October 19, 2021

    Report

    Report Number
    3014334038-2021-00214
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    October 3, 2021
    Report Date
    October 19, 2021
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    HBA
    UDI-DI
    10381780515005
    PMA / PMN Number
    K880402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS NOT RETURNED FOR EVALUATION; HOWEVER, A PHOTO WAS PROVIDED AND ANALYZED. DHR - THERE IS NO INDICATION THAT THE PRODUCTION PROCESS MAY HAVE CONTRIBUTED TO THIS COMPLAINT. ALL TEST RESULTS PASSED PROCEDURAL SPECIFICATIONS. FAILURE ANALYSIS - COMPLAINT CONFIRMED, 11 PATTIES PRESENTED IN THE PHOTO. THE COMPLAINT COULD BE VERIFIED THROUGH FAILURE ANALYSIS. ROOT CAUSE - THE COMPLAINT WAS CONFIRMED IN THE COMPLAINT INVESTIGATION. PER THE FAILURE ANALYST: ¿801404 PATTIES ARE PRODUCED USING HYBRID EQUIPMENT WHICH USES AND OPERATOR TO CYCLE THE MACHINE AND INSPECT THE PATTIES. THE MACHINE PRODUCES 10 PATTIES AND STACKS THEM FOR THE OPERATOR TO REVIEW. IT APPEARS THE MACHINE WAS CYCLED ONCE AND STOPPED AT THE FIRST PATTIE. WHEN THE OPERATOR RESET THE MACHINE THEY DID NOT CLEAR OUT THE PATTIES MADE THEN PRODUCED A STACK ON 10 ON TOP OF THE INITIAL 1. THIS RESULTED IN 11 PATTIES PRESENT. THE OPERATOR DID NOT PROPERLY INSPECT THE STACK OF 10 FOR PROPER COUNT. AN OPERATOR RETRAINING WILL BE COMPLETED TO ADDRESS THE ISSUE.¿ A CORRECTIVE ACTION WAS IMPLEMENTED TO FURTHER INVESTIGATE THE ISSUE.

    Description of Event or Problem · 1

    A FACILITY REPORTED THERE WERE 11 SURGICAL PATTIES IN THE PACKET INSTEAD OF 10. NO PATIENT INJURY REPORTED. IT IS UNKNOWN IF THE EVENT LED TO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559917 SURG PAT XRAY 1/2X1 1/2 SURGICAL PATTIES HBA INTEGRA LIFESCIENCES MANSFIELD 801404 5542810 10381780515005

    Patients

    Seq Age Sex Outcome Treatment
    1