BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE ENTERAL 3ML BNS

    MDR report key: 11599589 · Received March 31, 2021

    Report

    Report Number
    1213809-2021-00198
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 5, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2008403. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. THE RETAINED SAMPLES WERE EXAMINED AND NO SIGNS OF LEAKAGE WERE IDENTIFIED. IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM DAMAGE TO THE PLUNGER LIP COMPONENT. HOWEVER, LEAKAGE TESTING IS PERFORMED EVERY SHIFT OF PRODUCTION, AND NO ISSUES WERE DETECTED WITH THE PRODUCTION OF LOT NUMBER 2008403. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 100 SYRINGE ENTERAL 3ML BNS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BOX OF SYRINGES RECEIVED WITH DEFECTS, LEAK PAST THE PLUNGER.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: AN INVALID LOT # OF 2008403 WAS PROVIDED BY THE INITIAL REPORTER DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 100 SYRINGE ENTERAL 3ML BNS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BOX OF SYRINGES RECEIVED WITH DEFECTS, LEAK PAST THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491324 SYRINGE ENTERAL 3ML BNS SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2008403

    Patients

    Seq Age Sex Outcome Treatment
    1