BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML 18G 1-1/2IN

    MDR report key: 9834022 · Received March 16, 2020

    Report

    Report Number
    2243072-2020-00390
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 21, 2020
    Report Date
    March 19, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATIONS: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 191263. SBDM NOTICED THAT THERE WAS A CRACKED BARREL. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS FROM LOTS 1911223, 1912163 AND 1912173, NO ABNORMALITY OBSERVED. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 1912163, NO ABNORMALITY OBSERVED. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEWED THE CUSTOMER COMPLAINT RECORD, THERE WAS NO SAME ISSUE OF THE SAME PRODUCT FROM OTHER CUSTOMER. ROOT CAUSE: FROM INVESTIGATION, THE LIKELY CAUSE OF BROKEN BARREL MAY BE OCCURRED BEFORE THE SCALE PRINTING PROCESS. THIS PROCESS DEFECT MAY BE OCCURRED BY MALFUNCTION OF BARREL FEEDER IN THE ASSEMBLY MACHINE. IF THE BARREL MOVES TO ASSEMBLY MACHINE AND THERE ARE FULL OF BARRELS, SENSOR IS WORKING. IT MEANS THAT THE FEEDER AND SCALE PRINTING MACHINE STOPPED PROMPTLY AND RESUME THE RUN AGAIN. AN ERROR CAN BE OCCURRED BY THE TIME OF RE-RUN AND THEN THE FEEDER INDEX HIT AND BROKE THE BARREL. CORRECTIVE ACTIONS: SBDM CONDUCTED QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR SYRINGE ASSEMBLY LINE WORKERS AND QUALITY INSPECTORS. SBDM MAINTAIN THE BARREL FEEDING PART OF SYRINGE ASSEMBLY MACHINE TO PREVENT CRACK ON A BARREL. SBDM IMPLEMENTED 100% VISUAL INSPECTION ON SYRINGE PACKAGING PROCESS AND HAD RETRAINED ON INSPECTION METHOD FOR PACKAGING INSPECTOR DUE TO THIS COMPLAINT CASE. SBDM WILL STUDY TO UPGRADE FEEDING PART ON THE ASSEMBLY MACHINE, NOT AS STOP & GO BUT, CONTINUOUS FEEDING STYLE WITHOUT STOP. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML 18G 1-1/2IN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CRACKED BARREL. CRACKED BARREL LEAKAGE DRUG".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML 18G 1-1/2IN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CRACKED BARREL. CRACKED BARREL - LEAKAGE DRUG".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301640 SYRINGE 50ML 18G 1-1/2IN SYRINGE FMF BECTON DICKINSON 1912163

    Patients

    Seq Age Sex Outcome Treatment
    1 Other