BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7434686 · Received April 16, 2018

    Report

    Report Number
    1213809-2018-00201
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Date of Event
    February 22, 2018
    Report Date
    June 8, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A SINGLE LOOSE 10ML SYRINGE IN A BIOHAZARD BAG WAS RECEIVED, REPORTED TO BE FROM BATCH # 7150678 (P/N 301029). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE A DISTORTED STOPPER. THREE PHOTOS WERE RECEIVED DEPICTING A SINGLE 10ML ASSEMBLED SYRINGE REPORTED TO BE FROM BATCH #7150678 (P/N 301029). THE PHOTOS WERE EVALUATED. THE SYRINGE WAS FOUND TO HAVE JAMMED (DISTORTED) STOPPER. 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. COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE FIRST AND ONLY COMPLAINT FOR THIS CONDITION FOR BATCH #7150678 TO DATE. POTENTIAL ROOT CAUSE OF THE CONDITION IS LIKELY DUE TO A MISALIGNMENT OF THE PLUNGER ROD AND STOPPER WITH THE BARREL DURING THE ASSEMBLY PROCESS. CORRECTIVE ACTIONS: BASED ON THE INVESTIGATION RESULTS TO DATE THE DEFECT OBSERVED APPEARS TO HAVE BEEN AN ISOLATED INCIDENT WITH LIMITED IMPACT. (B)(4). NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME BASED ON THE DEFECTIVE RATE IDENTIFIED. CURRENT CONTROLS IN PLACE INCLUDE PERIODIC IN-PROCESS INSPECTIONS FOR ALL DEFECTS AT ASSEMBLY TO ENSURE CONTAINMENT OF DEFECT AND QUALITY OF THE FINAL PRODUCT. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 · 1

    IT WAS REPORTED THAT THE PLUNGER STOPPER WAS FOUND MISALIGNED ON A BD 10ML SYRINGE LUER-LOK¿ TIP WHICH COULD LEAD TO LEAKAGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278006 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7150678

    Patients

    Seq Age Sex Outcome Treatment
    1 Other