BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GU SYRINGE 1ML LS

    MDR report key: 15433950 · Received September 15, 2022

    Report

    Report Number
    3003152976-2022-00420
    Event Type
    Malfunction
    Date Received
    September 15, 2022
    Date of Event
    August 18, 2022
    Report Date
    November 16, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 2021010 WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION?: YES., D10: RETURNED TO MANUFACTURER ON: 16-NOV-2022 H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2021010. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, A SAMPLE WAS SUBMITTED TO OUR FACILITY WHICH DISPLAYED A WHITE AREA AT THE TIP OF THE SYRINGE. THE ISSUE HAS BEEN CONFIRMED. OUR SUPPLIER WAS NOTIFIED OF THIS EVENT AND WAS ABLE TO DETERMINE THE MOST LIKELY ROOT CAUSE FOR THIS EVENT. THE THICKENING OF THE SYRINGE AT THIS LOCATION IS INDICATIVE OF WIDENED POURING GATE IN THE MOULD.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD GU SYRINGE 1ML LS THERE WERE SCALE MARKING ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: A LESS PRECISE FIRST GRADUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD GU SYRINGE 1ML LS THERE WERE SCALE MARKING ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: - A LESS PRECISE FIRST GRADUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126225 BD GU SYRINGE 1ML LS PISTON SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown