BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH NEEDLE

    MDR report key: 8703800 · Received June 17, 2019

    Report

    Report Number
    2243072-2019-01194
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 31, 2019
    Report Date
    July 11, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 3 SAMPLES WERE RETURNED TO SBDM, LOT NUMBER IS 1812242. RETURNED SAMPLES LEAKAGE TEST: SBDM CONDUCTED LEAKAGE TEST ON THE 3 RETURNED SAMPLES AND RESULTS ARE: - WHEN PULLED STRAIGHT, THE SYRINGE SHOW NO LEAKAGE OR AIR ASPIRATION. - WHEN PULLED OBLIQUELY, THE SYRINGE SHOW NO LEAKAGE OR AIR ASPIRATION. RETURNED SAMPLES NEEDLE LEAK TEST: - WHEN PULLED STRAIGHT, THE NEEDLE SHOW NO LEAKAGE. - WHEN PULLED OBLIQUELY, THE NEEDLE SHOW NO LEAKAGE. LEAKAGE TEST BY AIR PRESSURE: SBDM CONDUCTED LEAK TEST OF THE COMPLAINT SAMPLES RECEIVED BY AIR PRESSURE UNDER 0.72MPA, THERE WAS NO LEAKAGE IN THE RECEIVED SAMPLE. DIMENSION MEASUREMENT: FOR THE RETURNED SAMPLE, SBDM MEASURED THE INTERNAL DIAMETER OF BARREL AND OUTER DIAMETER OF STOPPER. THE RESULTS SHOWS THE DIMENSION ARE WITHIN SPECIFICATIONS. BARREL INTERNAL DIAMETER: SPEC F20.05 +/- 0.05MM. SAMPLES WERE MEASURED AT F20.004, F20.010, F20.028. STOPPER OUTER DIAMETER: SPEC F21.0 + 0.05MM. SAMPLES WERE MEASURED AT F21.020, F21.003, F21.023. LEAK TEST RESULTS BY DIFFERENT BATCH OF STOPPER RAW MATERIAL: SBDM CONDUCTED THE LEAKAGE TEST ON 1,500 SAMPLES FROM 2 DIFFERENT BATCH OF STOPPER RAW MATERIAL, AFTER ALL MANUFACTURING PROCESS INCLUDED STERILIZATION. THERE WAS NO LEAKAGE IN A RAW MATERIAL LOT NO. 20190304-1 BUT, FOUND 2 LEAKAGE SAMPLE IN A RAW MATERIAL LOT NUMBER 20190311-1. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS FROM HOUSE SAMPLE LOTS 1812242, 1812262, 1901232, NO LEAKAGE WAS OBSERVED. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 1812242, NO ABNORMALITY WAS OBSERVED. ROOT CAUSE: FROM INVESTIGATION OF RETURNED SAMPLES, SBDM COULDN`T FIND AIR ASPIRATION IN THE COMPLAINT SAMPLES. THE INNER DIAMETER OF BARREL AND OUTER DIAMETER OF STOPPER IS IN SPEC FOR THE COMPLAINT SAMPLES. SBDM INDICATE POSSIBILITY OF STOPPER RAW MATERIAL SPECIFICATION BEING WIDE THAT CAUSE THE COMPLAINT CASE. THE STOPPER INJECTION CONDITION SHOULD BE CHANGED ACCORDING TO THE STOPPER RAW MATERIAL BATCH CHANGED BUT LINE WORKERS KEPT THE BEST INJECTION CONDITION THAT THEY FOUND BEFORE. SBDM WILL REQUEST TO RAW MATERIAL SUPPLIER TO MEET THE SPEC SIMILAR WITH RAW MATERIAL LOT NO. 20190304-1 THAT WAS TESTED WITH NO LEAKAGE USING CURRENT INJECTION CONDITION OF THE BARREL BY SBDM. ALSO, USING STOPPER RAW MATERIAL LOT NO. 20190311-1 SBDM FOUND 2 LEAKAGE SAMPLES WITH CURRENT INJECTION CONDITION. SBDM WILL TRY TO FIND THE BEST INJECTION CONDITION FOR THE BARREL TO MATCH THE STOPPER. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD¿ SYRINGES WITH NEEDLES LEAKED PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE THRU THE STOPPER"

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: 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 THAT 3 BD¿ SYRINGES WITH NEEDLES LEAKED PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE THRU THE STOPPER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497000 BD SYRINGE WITH NEEDLE PISTON SYRINGE FMF BECTON DICKINSON 1812242

    Patients

    Seq Age Sex Outcome Treatment
    1 Other