BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 15982623 · Received December 14, 2022

    Report

    Report Number
    9617032-2022-01263
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    November 17, 2022
    Report Date
    July 15, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMI
    PMA / PMN Number
    K022426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL #: 364314. LOT/BATCH #: 2091548. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR DEFORMED PLUNGER STOPPER WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND UPON COMPLETION THE INDICATED FAILURE MODE FOR DEFORMED PLUNGER STOPPER WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE DEFORMED PLUNGER STOPPER. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF DEFORMED PLUNGER STOPPER THROUGH CORRECTIVE AND PREVENTIVE ACTIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE, THE DEVICE EXPERIENCED A DEFORMED PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PLUNGER STOPPER BROKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE, THE DEVICE EXPERIENCED A DEFORMED PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PLUNGER STOPPER BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456245 BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE BLOOD SPECIMEN COLLECTION DEVICE FMI BECTON, DICKINSON AND COMPANY (BD) 2091548

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown