BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 12708304 · Received October 27, 2021

    Report

    Report Number
    3003152976-2021-00710
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    September 29, 2021
    Report Date
    November 23, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SYRINGE AND PHOTO RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION OF THE SAMPLE, LEAKAGE CAN BE CONFIRMED AS LIQUID WAS DETECTED PAST THE STOPPER. THE STOPPER IS CORRECTLY ASSEMBLED. WHEN BARREL IS EXAMINED, IT CAN BE SEEN THERE IS EXTERNAL DAMAGE BETWEEN 30 AND 40 MARKS OF THE SCALE. ADDITIONALLY, FUNCTIONAL TEST WAS PERFORMED ON SYRINGE AND NO LEAKAGE OBSERVED. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH HIT DURING ASSEMBLY PROCESS IN THE SILICONE STATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2012062 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SEAL AROUND THE PLUNGER APPEARS TO NOT BE INTACT, WHICH WAS DISCOVERED WHEN THE SYRINGE WAS INSTALLED IN A SYRINGE DRIVER PUMP FOR MEDICATION INFUSION. THE MEDICATION THEN BEGAN TO LEAK OUT BEHIND THE PLUNGER AND ON TO THE FLOOR."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SEAL AROUND THE PLUNGER APPEARS TO NOT BE INTACT, WHICH WAS DISCOVERED WHEN THE SYRINGE WAS INSTALLED IN A SYRINGE DRIVER PUMP FOR MEDICATION INFUSION. THE MEDICATION THEN BEGAN TO LEAK OUT BEHIND THE PLUNGER AND ON TO THE FLOOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605721 BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012062

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown