BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML 18G 1-1/2IN

    MDR report key: 10448005 · Received August 25, 2020

    Report

    Report Number
    2243072-2020-01295
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    August 3, 2020
    Report Date
    September 25, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 8/12/2020. H.6. INVESTIGATION: INVESTIGATIONS: 3 SAMPLES WERE RETURNED TO SBDM, LOT NUMBER IS 1004073. SBDM DONT RECEIVE EXACT SAME COMPLAINT SAMPLES DUE TO THE SAMPLES WERE CONTAMINATED BY BLOOD BUT RECEIVED WHICH IS NOT USED SAMPLES FROM CUSTOMER. LEAKAGE TEST OF COMPLAINT SAMPLES: SBDM CONDUCTED LEAKAGE TEST ON 3 COMPLAINT SAMPLES AND RESULTS ARE: - WHEN PULLED STRAIGHT, THE SYRINGE SHOW NO LEAKAGE. - WHEN PULLED OBLIQUELY, THE SYRINGE SHOW NO LEAKAGE. RETURNED SAMPLES NEEDLE LEAK TEST: - WHEN PULLED STRAIGHT, THE NEEDLES SHOW NO LEAKAGE. - WHEN PULLED OBLIQUELY, THE NEEDLES SHOW NO LEAKAGE. SBDM CONDUCTED LEAKAGE TEST ON 30 PCS RETENTION SAMPLES FROM LOTS 1003043, 1004073 & 1004212 AND RESULTS ARE: - WHEN PULLED STRAIGHT, THE SYRINGE SHOW NO LEAKAGE.. - WHEN PULLED OBLIQUELY, THE SYRINGE SHOW NO LEAKAGE. RETENTION SAMPLES NEEDLE LEAK TEST: - WHEN PULLED STRAIGHT, THE NEEDLES SHOW NO LEAKAGE. - WHEN PULLED OBLIQUELY, THE NEEDLES SHOW NO LEAKAGE. AIR PRESSURE TEST OF COMPLAINT SAMPLES: SBDM CONDUCTED AIR PRESSURE TEST OF THE COMPLAINT SAMPLE AND RETENTION SAMPLES BY AIR PRESSURE UNDER 3.0MPA (ABOUT 30.59¿/¿) AND 6.2MPA (ABOUT 63.22¿/¿), NO LEAKAGE IN THE RECEIVED SAMPLE. THE RESULTS OF DIMENSION MEASUREMENT (MEASURED BY PROFILE PROJECTOR): 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 F20.046, F20.053, F20.051 STOPPER OUTER DIAMETER: SPEC F21.0 + 0.05MM. SAMPLES WERE MEASURED AT F21.037, F21.044, F21.048 THE RESULTS OF VISUAL INSPECTION: SBDM CONDUCTED VISUAL INSPECTION BY A PROFILE PROJECTOR, WE DIDN`T FIND ANY DEFECTION IN A GASKET WHICH WAS RECEIVED SAMPLE FROM THE CUSTOMER. TEST BY PUMPING MACHINE: SBDM CONDUCT TEST BY PUMPING MACHINE, THE FLOW RATE IS ALMOST SAME AS SETTING AND THERE IS NO LEAKAGE. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS HOUSE SAMPLES FROM LOTS 1003043, 1004073 & 1004212, THERE WAS NO LEAKAGE IN THE HOUSE SAMPLES. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 1004073, THERE IS NO ISSUE WHILE MANUFACTURING. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEWED THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE (SYRINGE 20ML 18G 1-1/2IN), THERE WAS SIMILAR ISSUE OF THE SAME PRODUCT (SYRINGE 20ML 18G 1-1/2IN) FROM SAME CUSTOMER. ROOT CAUSE: BASED ON THE TEST RESULT OF THE COMPLAINT CASE BY COMPLAINT SAMPLES, SBDM CONCLUDED NO LEAKAGE IN THE COMPLAINT SAMPLES. HOWEVER, IT IS ASSUMED THAT THE CENTER BETWEEN PLUNGER AND BARREL WAS NOT MATCHED IN TEMPORARY WHILE SYRINGE ASSEMBLY PROCESS AND THE GASKET PUT BETWEEN PLUNGER AND WALL OF BARREL. OR IF THERE IS NO PROPER INJECTION CONDITION IN TEMPORARY WHILE GASKET INJECTION PROCESS, THE GASKET WOULD BE EJECTED WITH UNFORMED SHAPE SUCH AS TINY WHOLE IN THE MIDDLE OF GASKET. AND IT COULD CAUSE THIS COMPLAINT CASE. CORRECTIVE ACTIONS: 1. CONDUCT QUALITY TRAINING ON THE CUSTOMER COMPLAINT FOR STOPPER INSPECTION WORKERS AND QUALITY CONTROL WORKER. 2. STRENGTH INSPECTION FOR 20ML STOPPER AND WE ARE MONITORING THE LEAKAGE OF THE 20ML SYRINGE FOR EVERY LOT NO. BY ENHANCED INSPECTION METHOD (SIMILAR WITH CUSTOMER¿S USING CONDITION). 3. HAVE MAINTAINED AND CHECK CONDITION OF THE STOPPER INJECTION MOLD AND INJECTION MACHINE OF SYRINGE 20ML STOPPER. 4. MAINTAIN THE INDEX PART OF SYRINGE ASSEMBLY MACHINE TO PREVENT ASSEMBLY ERROR BETWEEN GASKET AND BARREL. 5. IMPLEMENTING 100% VISUAL INSPECTION ON SYRINGE PACKAGING PROCESS AND HAD RETRAINED ON INSPECTION METHOD FOR PACKAGING INSPECTOR DUE TO THIS COMPLAINT CASE EFFECTIVE. CONCLUSION: 3 SAMPLES WERE RETURNED TO SBDM, LOT NUMBER IS 1004073. SBDM DONT RECEIVE EXACTLY SAME COMPLAINT SAMPLES DUE TO THE SAMPLES WERE CONTAMINATED BY BLOOD BUT RECEIVED WHICH IS NOT USED SAMPLES FROM CUSTOMER. BASED ON THE TEST RESULT OF THE COMPLAINT CASE BY COMPLAINT SAMPLES, SBDM CONCLUDED NO LEAKAGE IN THE COMPLAINT SAMPLES. HOWEVER, IT IS ASSUMED THAT THE CENTER BETWEEN PLUNGER AND BARREL WAS NOT MATCHED IN TEMPORARY WHILE SYRINGE ASSEMBLY PROCESS AND THE GASKET PUT BETWEEN PLUNGER AND WALL OF BARREL. OR IF THERE IS NO PROPER INJECTION CONDITION IN TEMPORARY WHILE GASKET INJECTION PROCESS, THE GASKET WOULD BE EJECTED WITH UNFORMED SHAPE SUCH AS TINY WHOLE IN THE MIDDLE OF GASKET. AND IT COULD CAUSE THIS COMPLAINT CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD LEAKAGE OCCURRED DURING USE WITH 3 BD SYRINGE 20ML 18G 1-1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAK LIQUID BEHIND GASKET - ARTIFICIAL KIDNEY FOR KIDS ROOM - CONTAINED BLOOD.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKAGE OCCURRED DURING USE WITH 3 BD SYRINGE 20ML 18G 1-1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAK LIQUID BEHIND GASKET. ARTIFICIAL KIDNEY FOR KIDS ROOM, CONTAINED BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916647 BD SYRINGE 20ML 18G 1-1/2IN PISTON SYRINGE FMF BECTON DICKINSON 1004073

    Patients

    Seq Age Sex Outcome Treatment
    1 Other