BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE LUER-LOK¿

    MDR report key: 8133970 · Received December 5, 2018

    Report

    Report Number
    1213809-2018-00847
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 13, 2018
    Report Date
    February 7, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO AND ONE SEALED PACKAGED 3ML SYRINGE, CONFIRMED TO BE FROM BATCH #8140552 (P/N 309658), WERE RECEIVED AND VISUALLY EVALUATED. A LOOSE 3ML SYRINGE, POSSIBLY WITH LIQUID INSIDE, NEXT TO A PACKAGED SYRINGE WERE DEPICTED IN THE PHOTO. NO LEAKAGE COULD BE SEEN IN THE SYRINGE. HOWEVER, THE STOPPER AREA IN QUESTION WAS NOT WELL ILLUMINATED AND OUT OF FOCUS THEREFORE COULD NOT BE PROPERLY EVALUATED. THE RETURNED SAMPLE HAD NO VISUAL DEFECTS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE RETURNED SAMPLE WAS TESTED FOR LEAKAGE PAST STOPPER PER PROCEDURE. THE SYRINGE PASSED WITH NO LEAKAGE FOUND. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MEDICATION IN THE BD PLASTIPAK¿ SYRINGE LUER-LOK¿ LEAKED PAST THE STOPPER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MEDICATION IN THE BD PLASTIPAK¿ SYRINGE LUER-LOK¿ LEAKED PAST THE STOPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972637 BD PLASTIPAK¿ SYRINGE LUER-LOK¿ PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8140552 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other