BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD SYRINGE

    MDR report key: 11976315 · Received June 10, 2021

    Report

    Report Number
    1911916-2021-00547
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 14, 2021
    Report Date
    June 1, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    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

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: IT WAS REPORTED THE BARREL WAS BROKEN. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH NO PACKAGING FLOW WRAP AND THE BARREL WITH FLANGE DAMAGE. IT COULD BE POSSIBLE THAT A JAM OCCURRED AT THE PLUNGER ROD ASSEMBLY PROCESS INDUCING THE DAMAGE TO THE BARREL. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306594, LOT NUMBER 0161733. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE PLUNGER ROD ASSEMBLY PROCESS WAS PERFORMED. ALIGNMENT OF THE INFEED SCROLL AND SETTINGS WERE FOUND TO BE CORRECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD SYRINGE WAS FOUND TO BE DAMAGED BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE BARREL WAS BROKEN. THE CUSTOMER TOLD THE SALES REP TO OPEN THE PACKAGE AS SHOWN BELOW, AND THERE WAS NO DEBRIS IN THE BAG. THE NURSE WAS ANXIOUS TO USE THE BAG WITHOUT CAREFUL INSPECTION, AND THE SHARP EDGE WAS SCRATCHED AND BLEEDING. NOW THE ADVERSE EVENT HAS BEEN REPORTED TO THE ARMORY DEPARTMENT. THE ARMORY DEPARTMENT NEEDS TO ISSUE A SITUATION STATEMENT. PLEASE ASSIST IN ISSUING THE INVESTIGATION REPORT AS SOON AS POSSIBLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871202 UNSPECIFIED BD SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 0161733

    Patients

    Seq Age Sex Outcome Treatment
    1