BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML 18G 1-1/2IN

    MDR report key: 8704794 · Received June 17, 2019

    Report

    Report Number
    2243072-2019-01201
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 17, 2019
    Report Date
    July 8, 2019
    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 SUMMARY: 3 SAMPLES WAS RETURNED TO SBDM, LOT NUMBER IS UNKNOWN. FROM VISUAL INSPECTION, CRACK ON BARREL COULD BE FOUND. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS FROM LOTS 1901042, 1902182 & 1903262, NO ABNORMALITY OBSERVED. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FROM POTENTIAL LOTS 1901042, 1902182 & 1903262 FOR THE COMPLAINT SAMPLE, NO ABNORMALITY OBSERVED. CUSTOMER COMPLAINT REVIEW: SBDM REVIEWED THE CUSTOMER COMPLAINT RECORD, THERE ARE NO SIMILAR ISSUE FROM OTHER CUSTOMERS. ROOT CAUSE: FROM INVESTIGATIONS, THE LIKELY CAUSE IS THAT THE BROKEN BARREL MAY HAVE OCCURRED BEFORE THE SCALE PRINTING PROCESS DUE TO A MALFUNCTION OF THE BARREL & PLUNGER 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 OCCUR AT THE TIME OF RE-RUN AND THEN THE FEEDER INDEX HIT AND BROKE THE BARREL. IT IS ASSUMED THAT THE INSPECTORS COULD NOT FIND THE BROKEN BARREL OF SYRINGE AND IT CAUSED THE COMPLAINT CASE. CORRECTIVE ACTIONS: 1. SBDM CONDUCTED QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR SYRINGE ASSEMBLY LINE WORKERS AND QUALITY INSPECTORS. 2. SBDM IMPLEMENTED 100% VISUAL INSPECTION ON SYRINGE PACKAGING PROCESS AND HAD RETRAINED ON INSPECTION METHOD FOR PACKAGING INSPECTOR DUE TO THIS COMPLAINT CASE EFFECTIVE. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE 10ML 18G 1-1/2IN THE BODY OF THE SYRINGE IS BROKEN. THIS OCCURRED ON 3 SEPARATE OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PROBLEM OF BROKEN BODY OF SYRINGE.

    Additional Manufacturer Narrative · 1

    IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND AS GREATER ASIA IS AN OEM MANUFACTURING SITE. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE 10 ML 18 G 1-1/2IN THE BODY OF THE SYRINGE IS BROKEN. THIS OCCURRED ON 3 SEPARATE OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PROBLEM OF BROKEN BODY OF SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496832 SYRINGE 10ML 18G 1-1/2IN SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other