BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 15620477 · Received October 17, 2022

    Report

    Report Number
    1213809-2022-00720
    Event Type
    Malfunction
    Date Received
    October 17, 2022
    Date of Event
    September 21, 2022
    Report Date
    October 25, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095972
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ONE PHOTO WAS 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 BARREL DAMAGE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS AND MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1323475 AND 2091531. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    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 #: 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. INVESTIGATION SUMMARY: ONE PHOTO WAS 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 BARREL DAMAGE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS AND MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1323475 AND 2091531. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLES EXPERIENCED MOLDING DEFECTS, AND MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLASTIC DOSING SYRINGES WITH NEEDLE ATTACHED SLIGHTLY MALFORMED AND HAD NO DOSAGE MARKINGS. WAS THERE ANY PATIENT IMPACT? ¿ PATIENT WAS ABLE TO USE THE OTHER SYRINGES IN THE KIT TO OBTAIN DOSE. WAS TREATMENT SIGNIFICANTLY DELAYED? ¿ OTHER NEEDLES WERE USED, NO DELAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLES EXPERIENCED MOLDING DEFECTS, AND MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLASTIC DOSING SYRINGES WITH NEEDLE ATTACHED SLIGHTLY MALFORMED AND HAD NO DOSAGE MARKINGS. WAS THERE ANY PATIENT IMPACT? ¿ PATIENT WAS ABLE TO USE THE OTHER SYRINGES IN THE KIT TO OBTAIN DOSE. WAS TREATMENT SIGNIFICANTLY DELAYED? ¿ OTHER NEEDLES WERE USED, NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351505 BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309597 SEE H10 30382903095972

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown