BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML SALINE FILL CHINA SP

    MDR report key: 10114093 · Received June 3, 2020

    Report

    Report Number
    1911916-2020-00516
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    May 15, 2020
    Report Date
    May 27, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: THERE WAS NO SAMPLE NOR PHOTO PROVIDED FOR EVALUATION. ACCORDING TO THE COMPLAINT VERBATIM IT APPEARS THE BARREL WAS DAMAGED AND POSSIBLY CRACKED. A PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO THE DIVERTER AT THE PACKAGING PROCESS. IT COULD HAVE HAPPENED THAT A JAM OCCURRED AT THE DIVERTER INDUCING DAMAGE TO THE BARREL. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 2ND COMPLAINT FOR LOT # 9140777 FOR THIS TYPE OF DEFECT OR SYMPTOM. PREVIOUS COMPLAINT (B)(4). THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: A PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO THE DIVERTER AT THE PACKAGING PROCESS. IT COULD HAVE HAPPENED THAT A JAM OCCURRED AT THE DIVERTER INDUCING DAMAGE TO THE BARREL. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 5ML SALINE FILL (B)(4) SP HAD A DAMAGED BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PATIENT WAS ADMITTED TO THE HOSPITAL BECAUSE OF REPEATED ASTHMA AND DEPRESSION FOR 20 YEARS. INTRAVENOUS INFUSION WAS GIVEN WITH INDWELLING NEEDLE, AND THE TUBE WAS SEALED WITH A FLUSH. IT WAS FOUND THERE ARE CRACKS IN THE BARREL WHEN IT WAS OPENED, SO IT WAS REPLACED AND SEALED SUCCESSFULLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580403 SYRINGE 5ML SALINE FILL CHINA SP SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 9140777

    Patients

    Seq Age Sex Outcome Treatment
    1 Other