BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 2ML LS

    MDR report key: 18432065 · Received January 2, 2024

    Report

    Report Number
    2243072-2023-02260
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 5, 2023
    Report Date
    March 28, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    BARREL CRACK AND LEAKAGE OTHER BASED ON DHR REVIEW, NO ABNORMALITIES WERE OBSERVED DURING PRODUCTION. AT ASSEMBLY PROCESS THERE IS MECHANISM CONTROL TO CHECK THE STOPPER LEAKAGE. REVIEW OF THE DHR SHOWED THAT CHECKING SENSOR AND TESTING ON LEAK TEST STATION PER SHIFT WITH NO ABNORMALITY OBSERVED. CURRENT CONTROL THERE IS QA ROUTINE LEAK TEST INSPECTION IN PLACE TO CHECK FOR SYRINGE LEAKAGE. THERE IS AN IN-PROCESS INSPECTION DAMAGE COMPONENT FOR BARREL CRACK. QA OUTGOING INSPECTION THERE IS VISUAL INSPECTION FOR DAMAGED SYRINGE AS PER MQA-013/A. BASED ON THE RETURN SAMPLES, IT WAS OBSERVED DAMAGED BARREL IS NOTICED AT THE SAME POSITION, APPROXIMATELY AT THE LOCATION SCALE MARK AT ¿1/2ML AND 1ML¿ HEIGHT. THE TEAM HAS INVESTIGATED DIFFERENT SECTIONS OF MACHINE AND MATCHED POTENTIAL AREA WHICH COULD LEADING TO DAMAGED BARREL. THE PROBABLE ROOT CAUSE COULD BE DUE TO MACHINE OUTFEED DIAL ARE OUT OF ALIGNMENT WHICH EVENTUALLY LEADING TO PART SLANTING. THEREAFTER, THE PRODUCT TILTED FROM THE NEEDLE ASSEMBLY DIAL SLOT POCKET RESULTED CRASHED AND DAMAGED BY POCKET DIAL AND SIDE GUIDE DURING TRANSITION TO OUTFEED DIAL PROCESS. THE DEFECT PARTS FAILED TO REMOVE EFFECTIVELY BY PRODUCTION TECHNICIAN WHICH RESULTED ESCAPEES TO THE NEXT PROCESS. ACTION HAS BEEN TAKEN TO COMMUNICATE WITH PRODUCTION TECHNICIAN ON THE IMPORTANCE OF CLEARING JAMMED AND REMOVING DEFECTIVE PARTS AT IMMEDIATE ACTION AS IT MAY LED TO DAMAGED BARREL, THEREBY TO RAISE AWARENESS OF PRODUCTION TECHNICIAN ON THE REPORTED DEFECTS. THE AFFECTED BATCH RUN BEFORE THE ACTION TAKEN.

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DHR SHOWED THAT THE HOUSEKEEPING IS PERFORMED PER SHIFT PER 90005451 WITH NO ABNORMALITY OBSERVED. CURRENT CONTROL THERE IS A 3 HOURLY OUTGOING INSPECTION AS PER MQA-013/A CHECK FOR DAMAGE AND 2 HOURLY IN-PROCESS INSPECTION IN PLACE AS PER MFG-006/M TO CHECK FOR DAMAGE. DUE TO NO SAMPLE, NO PHOTO WAS RETURNED, ROOT CAUSE COULD NOT BE DETERMINED. COMPLAIN WILL BE MONITORED AND REOPENED IF SAMPLE IS RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 2ML LS LUER CRACKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF HAS NOTICED A CRACK ON 2ML SYRINGE 302204 LOT 3141695 WHICH LEAKS WHEN LIQUID IS DRAWN UP THE SYRINGE.

    Description of Event or Problem · 0

    STAFF HAS NOTICED A CRACK ON 2ML SYRINGE 302204 LOT 3141695 WHICH LEAKS WHEN LIQUID IS DRAWN UP THE SYRINGE.

    Description of Event or Problem · 0

    STAFF HAS NOTICED A CRACK ON 2ML SYRINGE 302204 LOT 3141695 WHICH LEAKS WHEN LIQUID IS DRAWN UP THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568166 BD SYRINGE 2ML LS SYRINGE FMF BECTON DICKINSON 3141695

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown