BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 8941633 · Received August 28, 2019

    Report

    Report Number
    2243072-2019-01833
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    August 9, 2019
    Report Date
    September 13, 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: INVESTIGATIONS: 145 SAMPLES WERE RETURNED TO SBDM, LOT NUMBER IS 1902262. COMPLAINT SAMPLES LEAKAGE TEST: SBDM CONDUCTED LEAKAGE TEST ON THE 145 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. COMPLAINT 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 COMPLAINT SAMPLES. DIMENSION MEASUREMENT: FOR THE 10 COMPLAINT SAMPLES, 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. 10 SAMPLES WERE MEASURED AND WITHIN SPECIFICATIONS. STOPPER OUTER DIAMETER: SPEC F21.0 + 0.05MM. SAMPLES WERE MEASURED AND WITHIN SPECIFICATIONS. LEAK TEST RESULTS BY DIFFERENT BATCH OF STOPPER RAW MATERIAL: SBDM CONDUCTED THE LEAKAGE TEST OF 1,500 SAMPLES IN EACH DIFFERENT BATCH OF STOPPER RAW MATERIAL, AFTER ALL MANUFACTURING PROCESS WAS FINISHED INCLUDED STERILIZATION. THERE WAS NO LEAKAGE IN A RAW MATERIAL LOT NO. 20190304-1 BUT, 2 LEAKAGE SAMPLE WERE FOUND IN A RAW MATERIAL LOT NUMBER 20190311-1. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 20 PCS HOUSE SAMPLES FROM LOTS 1901223, 1902262 AND 1904133, NO ABNORMALITY WAS OBSERVED. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 1902262, NO ABNORMALITY OBSERVED. ROOT CAUSE: FROM INVESTIGATION, SBDM COULD NOT FIND AIR ASPIRATION IN 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 HAS BEEN REPORTED THAT THE BD¿ SYRINGE HAS BEEN FOUND EXPERIENCING 150 OCCURRENCES OF LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: LEAK. A PHENOMENON IN WHICH BLOOD LEAKS BEHIND A PLUNGER WHILE BEING USED IN AN ARTIFICIAL KIDNEY ROOM.

    Additional Manufacturer Narrative · 1

    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. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE HAS BEEN FOUND EXPERIENCING 150 OCCURRENCES OF LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: LEAK. A PHENOMENON IN WHICH BLOOD LEAKS BEHIND A PLUNGER WHILE BEING USED IN AN ARTIFICIAL KIDNEY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732767 BD SYRINGE SYRINGE FMF BECTON DICKINSON 1902262

    Patients

    Seq Age Sex Outcome Treatment
    1 Other