BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 9662110 · Received February 3, 2020

    Report

    Report Number
    1213809-2020-00042
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 13, 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

    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 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 1 BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE FROM LOT# 9076761, AND 1 SYRINGE FROM LOT# 9070752 HAD DIFFICULT PLUNGER MOVEMENT DURING USE WHEN ENTERING THEM INTO THE "GATTEX" VIAL TO DRAW UP MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT CALLED TO REPORT SHE WAS HAVING DIFFICULTY WITH THE SUB-Q SYRINGE. PATIENT INDICATED WHEN SHE INSERTED THE SUB-Q SYRINGE INTO THE GATTEX VIAL, SHE WAS UNABLE TO DRAW THE MEDICATION OUT DUE TO THE SUB-Q SYRINGE PLUNGER BEING STUCK "ALMOST LIKE IT WAS GLUED STUCK"."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126122 BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309597 SEE SECTION H.10. 30382903095972

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other