BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 ML BD LUER-LOK SYRINGE

    MDR report key: 10708079 · Received October 20, 2020

    Report

    Report Number
    1911916-2020-00965
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 23, 2020
    Report Date
    October 1, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9269946, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-09-26, MEDICAL DEVICE LOT #: 9206753, MEDICAL DEVICE EXPIRATION DATE: 2024-07-31, DEVICE MANUFACTURE DATE: 2019-07-25, MEDICAL DEVICE LOT #: 9182276, MEDICAL DEVICE EXPIRATION DATE: 2024-06-30, DEVICE MANUFACTURE DATE: 2019-07-01. (B)(4). INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301031 AND LOT NUMBERS 9269946, 9206753 AND 9182276. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, NINE PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES CAME IN SEALED PLASTIC TRAYS WITH IN A KIT WITH DIFFERENT PRODUCTS. ONE 20ML SYRINGE WAS IN EACH KIT. EACH SYRINGE WAS TESTED FOR SUSTAINING FORCE AND, ALTHOUGH ON THE HIGHER END, WAS FOUND TO BE WITHIN SPECIFICATION. THE CUSTOMER WOULD HAVE NOTICED THE HIGHER FORCE REQUIRED INDUCING THE DISSATISFACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 20 ML BD LUER-LOK¿ SYRINGES EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301031 BATCH NO: 9269946. SYRINGES IN KITS ARE EXTREMELY DIFFICULT TO WITHDRAW AND ADMINISTER MEDICATIONS. THIS INCLUDES THE REFILL KIT AS WELL AS THE DRUG PREPARATION KIT. THEY ARE NOT GLIDING AS EASILY AS THEY USUALLY DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173744 20 ML BD LUER-LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other