BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURG PAT XRAY 1/2X1 1/2

    MDR report key: 17868218 · Received October 4, 2023

    Report

    Report Number
    3014334038-2023-00164
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    July 31, 2023
    Report Date
    February 8, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    HBA
    UDI-DI
    10381780515005
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: EVENT DATE : 31/07/2023. PRODUCT REFERENCE: 801404 LOT NUMBER: 6756705. WHEN WAS IT NOTICED? "PRE-OPERATIVE SETUP AND CHECKS". WAS THE PATIENT UNDER ANESTHESIA? "YES". HOW DID YOU FINALIZE THE PROCEDURE? "REMOVED AND ISOLATED FAULTY ITEMS AND ALL PACKETS WITH SAME LOT NUMBER". WAS THERE ANY SURGICAL DELAY DUE TO THIS ISSUE? "NO". WAS THERE ANY CONSEQUENCE(S) FOR THE PATIENT HEALTH? "NO CONSEQUENCE ERROR DISCOVERED PRIOR TO SURGICAL KNIFE TO SKIN".

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    PATTIES WERE RETURNED FOR EVALUATION: DHR - THERE IS NO INDICATION THAT THE PRODUCTION PROCESS MAY HAVE CONTRIBUTED TO THIS COMPLAINT. ALL TEST RESULTS PASSED PROCEDURAL SPECIFICATIONS. FAILURE ANALYSIS - THE PATTIE/STRIP UNIT WAS INSPECTED BY THE FAILURE EVALUATOR. PER THE FAILURE EVALUATOR, THE 3 EXTRA PATTIES WERE PRESENT ON THE CARD, REMAINING PATTIES PRESENT ON THE CARD WERE ALL ACCEPTABLE PER MANUFACTURING SPECIFICATIONS. THE COMPLAINT COULD BE VERIFIED THROUGH FAILURE ANALYSIS. ROOT CAUSE - PER THE COMPLAINT BACKGROUND, 13 PATTIES IN A PACK OF 10. THE COMPLAINT WAS CONFIRMED IN THE COMPLAINT INVESTIGATION. PER THE FAILURE EVALUATOR, THE OPERATOR WORKING ON THIS LOT HAD AN ALARM ALERT THEM TO AN ISSUE WITH THE STRING OF THE PATTIE FEEDING PROPERLY, AND AFTER CORRECTING THE STRING FEEDING ISSUE, THE COUNT ON THE STACK BEING PRODUCED WHEN THE ALARM WENT OFF WAS NOT CONFIRMED AND THE THREE EXTRA PATTIES MADE PRIOR TO THE ALARM MADE IT ON TO THE NEXT STACK OF 10 BEING PRODUCED ONCE THE ALARM WAS CORRECTED. THIS IS ATTRIBUTED TO OPERATOR ERROR FOR FAILURE TO CONFIRM THE COUNT AFTER AN ALARM. THERE IS CURRENTLY AN OPEN CORRECTIVE AND PREVENTATIVE ACTION (CAPA) FOR THE PATTIES/STRIPS PRODUCT FAMILY RELATED TO X-RAY POLYMER ISSUES, STRING ISSUES AND INCORRECT COUNT.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    A FACILITY REPORTED A PATTIE PACKAGING WITH 13 PATTIES IN A PACKET OF 10. THE 3 EXTRA PATTIES HAD NO STRING. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353744 SURG PAT XRAY 1/2X1 1/2 SURGICAL PATTIES HBA INTEGRA LIFESCIENCES MANSFIELD 6756705 10381780515005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown