BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9521779 · Received December 26, 2019

    Report

    Report Number
    1213809-2019-01308
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    December 2, 2019
    Report Date
    January 6, 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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, SO 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.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 1ML S/T W/NDL 26X5/8 RB HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF CLOGGED NEEDLES DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHEN THE PATIENT WOULD DRAW BACK THE NEEDLE TO OBTAIN MEDICATION, NOTHING WOULD GO THROUGH THE NEEDLE. PATIENT TRIED TWICE WITH 2 DIFFERENT NEEDLES, AND ON THE 3RD NEEDLE PATIENT WAS ABLE TO DRAW UP MEDICATION. IT WAS REPORTED: PATIENT ADVISED SHE WAS NOT ABLE TO DRAW UP MEDICATION TODAY WITH 2 NEEDLES. WHEN PATIENT WOULD DRAW BACK NEEDLE TO OBTAIN MEDICATION, NOTHING WOULD GO THROUGH NEEDLE. PATIENT TRIED TWICE WITH 2 DIFFERENT NEEDLES, AND ON THE 3RD NEEDLE PATIENT WAS ABLE TO DRAW UP MEDICATION.

    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 #: 8221735, MEDICAL DEVICE EXPIRATION DATE: 2023-07-31, DEVICE MANUFACTURE DATE: 2018-08-09. 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 CLOGGED NEEDLES DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHEN THE PATIENT WOULD DRAW BACK THE NEEDLE TO OBTAIN MEDICATION, NOTHING WOULD GO THROUGH THE NEEDLE. PATIENT TRIED TWICE WITH 2 DIFFERENT NEEDLES, AND ON THE 3RD NEEDLE PATIENT WAS ABLE TO DRAW UP MEDICATION. IT WAS REPORTED: PATIENT ADVISED SHE WAS NOT ABLE TO DRAW UP MEDICATION TODAY WITH 2 NEEDLES. WHEN PATIENT WOULD DRAW BACK NEEDLE TO OBTAIN MEDICATION, NOTHING WOULD GO THROUGH NEEDLE. PATIENT TRIED TWICE WITH 2 DIFFERENT NEEDLES, AND ON THE 3RD NEEDLE PATIENT WAS ABLE TO DRAW UP MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317011 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 Other