BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 9677477 · Received February 6, 2020

    Report

    Report Number
    1213809-2020-00068
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 15, 2020
    Report Date
    January 21, 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 WAS REPORTED THAT 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE WAS UNABLE TO DRAW BECAUSE THE PLUNGER WAS STUCK. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309597 BATCH NO.: 9076761 AND 9070752. IT WAS REPORTED THAT THE CAREGIVER WAS UNABLE TO DRAW THE GATTEX SOLUTION OUT OF THE VIAL BECAUSE THE PLUNGER WAS STUCK. 7 SYRINGES WERE USED WITH THE SAME ISSUE. HE WAS ABLE TO USE ANOTHER PRODUCT ON HAND. NO AE OR OTHER INFORMATION HAS BEEN REPORTED. PER SHIRE COMPLAINT RECORD REPORT: CAREGIVER SON REPORTED HAVING DIFFICULTY WITH THE SUB- Q SYRINGES. CAREGIVER INDICATED WHEN HE INSERTED THE SUB - Q SYRINGE INTO THE GATTEX VIAL, HE WAS UNABLE TO DRAW THE MEDICATION OUT DUE TO SUB-Q PLUNGER BEING STUCK. UNFORTUNATELY, HE WASTED 7 SUB - Q SYRINGES AND WAS ABLE TO USE OTHER PRODUCT IN HAND. NO AE OR OTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142838 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309597 SEE H.10 30382903095972

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other