BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH NEEDLE

    MDR report key: 8020280 · Received October 30, 2018

    Report

    Report Number
    2243072-2018-01534
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 10, 2018
    Report Date
    January 14, 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

    INVESTIGATION SUMMARY: FOUR SAMPLES WERE RETURNED TO SBDM, LOT NUMBER 180723. THE INFORMATION PROVIDED BD KOREA SALES ON THE LOT NUMBER WAS WRONG, THERE WAS NO LOT 180723. SBDM CONDUCTED LEAKAGE TEST ON 5 LOTS (1807103, 1807123, 1807303, 1807313 AND 1808023), WHICH WERE MANUFACTURED (10 JUL TO 02 AUG) BEFORE THE COMPLAINT DATE. 5 PCS FROM EACH LOT WERE TESTED FOR LEAKAGE, NO LEAKAGE WERE OBSERVED. SBDM REVIEWED THE DHR MANUFACTURING RECORDS FOR LOTS 1807103, 1807123, 1807303, 1807313 AND 1808023, NO ABNORMALITY WAS OBSERVED. SBDM REVIEWED INTERNAL CUSTOMER COMPLAINT RECORD, THERE WERE NO SIMILAR ISSUE FOR SAME PRODUCT FROM OTHER CUSTOMERS. INVESTIGATION CONCLUSION: SBDM INSPECTED THE 4 SAMPLES, AND NOTICED LEAKAGE FROM THE BARREL TIP, THE CAVITY NUMBER OF THE BARREL IS NUMBER 3. SBDM CONDUCTED INSPECTION FOR 50 BARRELS OF CAVITY NO.3 AND THERE WAS NO LEAKAGE. ROOT CAUSE DESCRIPTION: BASED ON INVESTIGATION AND ANALYSIS ON THE COMPLAINT CASE (LEAKAGE ON THE SYRINGE BARREL TIP), THE LEAKAGE WAS ATTRIBUTED TO BARREL CAVITY 3. THE LIKELY CAUSE IS THAT THE EJECTOR OF SYRINGE BARREL MOLD WAS PUSHED OUT SO HARD THAT IT DAMAGED THE COMPLAINT BARREL TIP PART (CAVITY NO 3). RATIONALE: CORRECTIVE ACTIONS: 1. SBDM HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR SYRINGE MANUFACTURING LINE AND INJECTION MOLDING LINE WORKERS AND QUALITY INSPECTORS. 2. SBDM STRENGTHEN PROCESS INSPECTION OF SYRINGE MOLDING MANUFACTURING LINE AS WELL AS SYRINGE ASSEMBLY LINE AND KEEP MONITORING OF THE PROCESSES TO SEE IF THE SAME TYPE OF COMPLIANT OCCURS AGAIN. 3. SBDM INSPECTED 50 BARRELS OF CAVITY NO.3 AND THERE WAS NO LEAKAGE. 4. SBDM ADJUSTED REST MOLDING CONDITION ESPECIALLY ON EJECTION PRESSURE (FROM 90 TO 80) AND EJECTION SPEED (FROM 85 TO 75) OF THE MOLDING MACHINE IN ORDER NOT TO TOUCH WITH MOLDING PARTS. 5. SBDM CONDUCTED INSPECTION OF ALL CAVITIES UNDER CHANGED INJECTION CONDITION FOR SYRINGE 50ML BARREL, (12 SHOTS PER DAY FROM (B)(6) TO (B)(6) 2018) THERE WAS NO LEAKAGE AFTER CHANGING INJECTION WORK CONDITION. SBDM HAS IN HOUSE CAPA-18-098 ON FILE TO MONITOR TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD¿ SYRINGE WITH NEEDLE THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD¿ SYRINGE WITH NEEDLE THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861476 BD¿ SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other