BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML S/T BNS

    MDR report key: 11770105 · Received May 4, 2021

    Report

    Report Number
    1213809-2021-00287
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 5, 2021
    Report Date
    April 21, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: (B)(6). INVESTIGATION SUMMARY: TWO PHOTOS WERE RECEIVED AND EVALUATED. ONE PHOTO DISPLAYED A SINGLE LOOSE 5ML SYRINGE AND ONE PHOTO APPEARED TO DISPLAY THE SAME LOOSE SYRINGE AND AN ADDITIONAL LOOSE 5ML SYRINGE. IT WAS OBSERVED ONE OF THE TWO SYRINGES SHOWN HAD THE PLUNGER ROD IN THE BOTTOM OUT POSITION WITH A PORTION OF THE STOPPER WEDGED BETWEEN THE BARREL WALL AND PLUNGER ROD. THE JAMMED STOPPER CONDITION WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE JAMMED/DISTORTED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0080420 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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. 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. INVESTIGATION CONCLUSION: THE AQL FOR INCORRECT ASSEMBLY IS 0.65%. THE DEFECTIVE RATE IDENTIFIED IS 1 OUT OF 672,000, WHICH IS 0.0001%. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0080420 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT LEAST 1 SYRINGE 5ML S/T BNS EXPERIENCED A DEFECTIVE/DAMAGED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301028, BATCH NO.: 0080420. WHILE PREPARING SAMPLES FOR LAL TESTING, THE PLUNGER TIP FOR THE 5ML SYRINGE WAS OBSERVED TO BE DEFORMED IN 1 OUT OF 6 KITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666580 SYRINGE 5ML S/T BNS SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0080420

    Patients

    Seq Age Sex Outcome Treatment
    1