BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 11497168 · Received March 16, 2021

    Report

    Report Number
    3003152976-2021-00143
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 16, 2021
    Report Date
    March 9, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT HAS BEEN RECEIVED 1 USED SAMPLE OF 50LL LOT 2003287 AND 2 PICTURES FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE USED SAMPLE AND 2 PICTURES RECEIVED, IT CAN BE OBSERVED THE SYRINGE BARREL IS DAMAGED, IT IS DENTED AT 30ML MARK OF THE SCALE. THIS DAMAGE IS THE CAUSE OF THE LEAKAGE SINCE WHEN PLUNGER IS MOVED AT THIS POINT STOPPER RESULTS DISTORTED AGAINST BARREL WALLS AND DRUG PASS THE STOPPER. THE DAMAGE HAS BEEN CAUSED BECAUSE SYRINGE RESULTED JAMMED IN THE WHEELS OF ASSEMBLY MACHINE DURING MANUFACTURING PROCESS SINCE MARK OF ASSEMBLY WHEEL CAN BE OBSERVED ON THE BARREL AFTER IT WAS PRINTED. DHR OF LOT 2003287 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. ALTHOUGH NO ISSUES WERE IDENTIFIED AND MANUFACTURING RECORD STABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY, ACCORDING TO SAMPLE AND PICTURES RECEIVED, WE CAN CONFIRM THAT THE ROOT CAUSE OF THE NON-CONFORMANCE IS RELATED WITH BARREL JAMMED DURING ASSEMBLY PROCESS. CAPA WAS INITIATED IN FEBRUARY 2020 FOR REDUCTION OF JAMMED BARRELS IN THIS ASSEMBLY MACHINE AND IT WAS COMPLETED AS EFFECTIVE ON JANUARY 2021. LOT 2003287 WAS MANUFACTURED IN MARCH 2020. NO COMPLAINTS HAVE BEEN RECEIVED FOR THIS DEFECT AFTER THIS CAPA WAS CLOSED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICATION LEAKED FROM A CRACK IN THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE BARREL BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE INCIDENT OCCURRED WHEN PREPARING MEDICIN IN THE SYRINGE. THE NURSE OBSERVED MEDICATION DRIPPING FROM THE SYRINGE AND DISCOVERED A CRACK IN THE SYRINGE BARREL. THE SYRINGE WAS NOT USED FOR PATIENTS. NO DAMAGE TO THE PACKAGING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393649 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2003287

    Patients

    Seq Age Sex Outcome Treatment
    1