BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 16383632 · Received February 15, 2023

    Report

    Report Number
    1213809-2023-00090
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    January 24, 2023
    Report Date
    March 4, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903095971
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1323475; MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2026; DEVICE MANUFACTURE DATE: 19-NOV-2021. MEDICAL DEVICE LOT #: 2091531; MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027; DEVICE MANUFACTURE DATE: 01-APR-2022.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT THE BARREL IS DAMAGED AND MISSING ALL ITS SCALE MARKINGS. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT AND BARREL DAMAGED DEFECTS IS ASSOCIATED WITH THE MARKING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 1323475 AND 2091531. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 OF THE BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE HAD NO MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO MARKINGS ON SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 OF THE BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE HAD NO MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO MARKINGS ON SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390194 BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 00382903095971

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown