BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML 18G 1-1/2IN

    MDR report key: 10588324 · Received September 25, 2020

    Report

    Report Number
    2243072-2020-01505
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    July 1, 2020
    Report Date
    September 10, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1912133. VISUAL INSPECTION OF THE COMPLAINT SAMPLE: SBDM CONDUCT VISUAL INSPECTION OF THE RECEIVED COMPLAINT SAMPLE, THE TIP OF THE SAMPLE WAS BROKEN. HOUSE SAMPLE INVESTIGATION RESULT: SBDM CHECKED TOTAL 75 PIECES OF SAME AND SIMILAR LOT 1911223, 1912133 & 1912193 HOUSE SAMPLES, THERE WAS NO SUCH CASE OF BROKEN OR DAMAGED SYRINGE TIP. DHR REVIEW: SBDM REVIEW THE MANUFACTURING RECORD OF SAME LOT WITH COMPLAINT SAMPLES LOT NO. 1912133, THERE IS NO ISSUE WHILE MANUFACTURING. CUSTOMER COMPLAINT RECORD REVIEW OF COMPLAINT SAMPLE: SBDM INVESTIGATE THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE, THERE IS NO SAME ISSUE OF THE SAME PRODUCT FROM OTHER CUSTOMER. INVESTIGATION CONCLUSION: 1 SAMPLE WAS RETURNED TO SBDM. FROM INVESTIGATION, SBDM CHECKED THE SYRINGE ASSEMBLY PACKING PROCESS, WE SUPPOSE THAT THE DAMAGE MAY BE OCCURRED WHILE MOVING TO PACKING PROCESS AFTER SYRINGE ASSEMBLY PROCESS. THE COMPLAINT SYRINGE MAY NOT BE SETTLED INTO FEEDER CORRECTLY AND IT MAY BE BUMPED ONTO THE GUARD. THEN THE DAMAGED(CRACKED) SYRINGE MAY BE PACKED BEING BROKEN. ROOT CAUSE DESCRIPTION: FROM INVESTIGATION, SBDM CHECKED THE SYRINGE ASSEMBLY PACKING PROCESS, WE SUPPOSE THAT THE DAMAGE MAY BE OCCURRED WHILE MOVING TO PACKING PROCESS AFTER SYRINGE ASSEMBLY PROCESS. THE COMPLAINT SYRINGE MAY NOT BE SETTLED INTO FEEDER CORRECTLY AND IT MAY BE BUMPED ONTO THE GUARD. THEN THE DAMAGED(CRACKED) SYRINGE MAY BE PACKED BEING BROKEN. CORRECTIVE ACTIONS: QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR SYRINGE ASSEMBLY LINE WORKERS AND QUALITY INSPECTOR. STRENGTHENING PROCESS MONITORING & PRODUCT INSPECTION FOR SYRINGE PRODUCTS. MAINTAINED THE SIDE GUARD OF SYRINGE ASSEMBLY & PACKING MACHINE BY REGULATING IT A LITTLE BACKWARD TO PROTECT THE COMPLAINT CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML 18G 1-1/2IN TIP WAS BROKEN. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE TIP IS BROKEN BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055352 SYRINGE 50ML 18G 1-1/2IN SYRINGE FMF BECTON DICKINSON 1912133

    Patients

    Seq Age Sex Outcome Treatment
    1 Other