BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE

    MDR report key: 16981579 · Received May 22, 2023

    Report

    Report Number
    3002682307-2023-00131
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    April 29, 2023
    Report Date
    August 10, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1 INITIAL REPORTER ADDR 1: (B)(6). H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY AS SAMPLES WERE UNAVAILABLE FOR THIS RETURN, TWENTY (20) RETAINED SAMPLES WERE OBTAINED FOR EVALUATION BY OUR INVESTIGATIVE TEAM. THE RETAINED SAMPLES WERE EXAMINED; HOWEVER, NO SIGNS OF DEFECT WERE IDENTIFIED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300330 AND LOT NUMBER 2210509. THE REVIEW DID REVEAL ONE POTENTIALLY RELATED QUALITY NOTIFICATION DURING THE PRODUCTION PROCESS RELATED TO DAMAGED PLUNGER RODS WHICH WAS RESOLVED AT THE TIME OF DETECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 OF THE BD DISCARDIT¿ II SYRINGES WITH DETACHED BD MICROLANCE¿ NEEDLES EXPERIENCED LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DRUG/MEDICATION LEAKAGE FROM THE BACKSIDE OF PLUNGER WHILE ASPIRATING DRUGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 OF THE BD DISCARDIT¿ II SYRINGES WITH DETACHED BD MICROLANCE¿ NEEDLES EXPERIENCED LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DRUG/MEDICATION LEAKAGE FROM THE BACKSIDE OF PLUNGER WHILE ASPIRATING DRUGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182434 BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2210509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown