BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 9437776 · Received December 9, 2019

    Report

    Report Number
    1213809-2019-01236
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    November 18, 2019
    Report Date
    December 11, 2019
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    MATERIAL NO: 309597, BATCH NO: 9076761, 8221735. IT WAS REPORTED THAT DURING USE OF THE 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE THE CONSUMER WAS NOT ABLE TO DRAW UP INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT COMPLAINED ABOUT THE NEEDLE SYRINGES THAT ARE USED TO WITHDRAW THE MEDICATION UP FROM THE VIAL. SHE TRIED FOUR TIME AND WAS NOT SUCCESSFUL. FINALLY USING A FIFTH NEEDLE WAS USED AND SHE WAS SUCCESSFUL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 #: 8221735. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2018-08-09. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO: 309597, BATCH NO: 9076761, 8221735. IT WAS REPORTED THAT DURING USE OF THE 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE THE CONSUMER WAS NOT ABLE TO DRAW UP INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT COMPLAINED ABOUT THE NEEDLE SYRINGES THAT ARE USED TO WITHDRAW THE MEDICATION UP FROM THE VIAL. SHE TRIED FOUR TIME AND WAS NOT SUCCESSFUL. FINALLY USING A FIFTH NEEDLE WAS USED AND SHE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237073 1 ML 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 Other