BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE 1ML S/T W/NDL 26X5/8 RB

    MDR report key: 9660339 · Received February 3, 2020

    Report

    Report Number
    1213809-2020-00039
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 9, 2020
    Report Date
    January 15, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095972
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9076761, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-03-17, MEDICAL DEVICE LOT #: 9070752, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-03-11. 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 HAS BEEN REPORTED THAT THE BD¿ SYRINGE 1ML S/T W/NDL 26X5/8 RB HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHILE DRAWING UP A DOSAGE, THERE WAS LEAKING COMING DOWN THE NEEDLE ONTO THE SYRINGE. PER EMAIL: FIELD NURSE REPORTS THAT THIS WAS THE SECOND TRAINING WITH THE PATIENT. THEY WERE FOLLOWING THE IFU. THEY WERE AT STEP 5 IN THE IFU, WHILE DRAWING UP THE DOSE INTO THE SYRINGE, THE PATIENT AND NURSE NOTICED DROPS OF LIQUID COMING OUT. THE DROPS WERE COMING DOWN THE NEEDLE ONTO THE SYRINGE. THEY COULD NOT DETERMINE WHERE THE DROPS WERE COMING FROM. PATIENT WAS ABLE TO DRAW UP AND GIVE HERSELF HER FULL DOSE. NO REPLACEMENT PRODUCT IS NEEDED AS PATIENT WAS ABLE TO DRAW UP AND GIVE HERSELF THE FULL DOSE. THE FIELD NURSE HAD THE PATIENT SAVE THE VIAL. NO AE INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126197 BD¿ SYRINGE 1ML S/T W/NDL 26X5/8 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309597 SEE H.10 30382903095972

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other