BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML 21G 1-1/4IN

    MDR report key: 8444367 · Received March 22, 2019

    Report

    Report Number
    2243072-2019-00554
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Date of Event
    March 5, 2019
    Report Date
    May 23, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382905900747
    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: 79 SAMPLES WERE RETURNED TO SBDM, LOT NUMBER IS 1809133 & 1811062. RETURNED SAMPLES LEAKAGE TEST: SBDM CONDUCTED LEAKAGE TEST ON THE 79 RETURNED SAMPLES AND RESULTS ARE: - WHEN PULLED STRAIGHT, THE SYRINGES SHOW NO LEAKAGE OR AIR ASPIRATION. - WHEN PULLED OBLIQUELY, THE SYRINGES SHOW NO LEAKAGE OR AIR ASPIRATION. RETURNED SAMPLES NEEDLE LEAK TEST: - WHEN PULLED STRAIGHT, THE NEEDLES SHOW NO LEAKAGE. - WHEN PULLED OBLIQUELY, THE NEEDLES 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 79 RECEIVED SAMPLES. DIMENSION MEASUREMENT: FOR THE 79 RETURNED SAMPLES, SBDM MEASURED 4 PCS FOR 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 F20.023, F20.613, F20.431, F20.035 STOPPER OUTER DIAMETER: SPEC F21.0 + 0.05MM. SAMPLES WERE MEASURED AT F20.931, F21.014, F21.039, F21.024 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. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 1809133, 1811062, 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. SBDM HAS IN HOUSE CAPA-19-015 IN PLACE TO MONITOR DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 20ML 21G 1-1/4IN HAD LEAKAGE. THE FOLLOWING WAS REPORTED, "AIR WAS GENERATED DURING TAKING A BLOOD SAMPLE AT THE MEDICAL CHECK CENTER. BLOOD WAS CAME OUT BEHIND A GASKET."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). 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. 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 A SYRINGE 20ML 21G 1-1/4IN HAD LEAKAGE. THE FOLLOWING WAS REPORTED, "AIR WAS GENERATED DURING TAKING A BLOOD SAMPLE AT THE MEDICAL CHECK CENTER. BLOOD WAS CAME OUT BEHIND A GASKET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236131 SYRINGE 20ML 21G 1-1/4IN HYPODERMIC SYRINGE W/ NEEDLE FMI BECTON DICKINSON 1811062 00382905900747

    Patients

    Seq Age Sex Outcome Treatment
    1 Other