BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 14731438 · Received June 17, 2022

    Report

    Report Number
    3002682307-2022-00167
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    May 17, 2022
    Report Date
    June 1, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300321 AND LOT NUMBER 2202188. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURES OF THE AFFECTED SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. HOWEVER, THROUGH EXAMINATION OF THE PICTURES ALONE, WE ARE UNABLE TO CONFIRM THE DEFECT OF SCALE MARKING MISSING AS IT IS POSSIBLE THAT THE SYRINGE IS TURNED WITHIN THE PACKAGE, HIDING THE MARKINGS. ONE SHELF CARTON OF RETAINED SAMPLES WAS OBTAINED FOR FURTHER EVALUATION; HOWEVER, THE RETAINED SAMPLES DID NOT DISPLAY ANY SIGNS OF DEFECT. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II SYRINGE WAS FOUND WITHOUT SCALE MARKINGS DURING THE PACKAGING PROCESS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING PACKAGING OF FINISHED PRODUCT (FP) BATCH FR5060 ON PACKAGING LINE (PL) 03, ONE BLISTER OF BATCH 2001513532 (ITEM PPU5N0376, VENDOR BATCH 2202188) IS FOUND WHICH CONTAINS... AN INCORRECT SYRINGE (MISSING GRADATION INDICATION)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397548 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2202188

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown