BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML 18G 1-1/2IN

    MDR report key: 11159064 · Received January 13, 2021

    Report

    Report Number
    2243072-2021-00083
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 15, 2020
    Report Date
    February 9, 2021
    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: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-12-28 H6: INVESTIGATION SUMMARY 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1904133. WATER LEAK TEST OF COMPLAINT SAMPLES: THERE WAS NO LEAKAGE ON THE COMPLAINT SAMPLE SYRINGE AND NEEDLE WHEN PULLED STRAIGHT AND OBLIQUELY. WATER LEAK TEST RESULTS OF RETENTION SAMPLES: SBDM TESTED 30 PCS RETENTION SAMPLES FROM LOTS 1902262, 1904133,1904152. THERE WAS NO LEAKAGE ON ALL 30 RETENTION SAMPLE SYRINGES AND NEEDLES WHEN PULLED STRAIGHT AND OBLIQUELY. 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¿/¿), DIDN¿T FIND LEAKAGE IN THE RECEIVED SAMPLE. THE RESULTS OF DIMENSION MEASUREMENT (MEASURED BY PROFILE PROJECTOR): INTERNAL DIAMETER OF 20ML BARREL MEASURED FITS THE SPECIFICATION. 20ML BARREL INTERNAL DIAMETER SPEC: F20.05+/-0.05MM, RESULTS F20.040 EXTERNAL DIAMETER OF 20ML STOPPER MEASURED FITS THE SPECIFICATION. 20ML STOPPER 1ST RING SPEC: F21.0 +0.05MM, RESULTS F21.037 THE RESULTS OF VISUAL INSPECTION: SBDM CONDUCTED VISUAL INSPECTION BY A PROFILE PROJECTOR, 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 ON THE COMPLAINT SAMPLE. HOUSE SAMPLE INSPECTION: SBDM CHECKED THE SAME AND OTHER LOT (LOT NO. 1902262, 1904133 & 1904152) OF HOUSE SAMPLES AS OF THE COMPLAINT SAMPLE, THERE WAS NO LEAKAGE IN THE HOUSE SAMPLES. DHR REVIEW: SBDM REVIEW THE MANUFACTURING RECORD OF COMPLAINT SAMPLE (LOT NO. 1904133), THERE IS NO ISSUE WHILE MANUFACTURING. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEW THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE (SYRINGE 20ML 18G 1-1/2IN), THERE WAS SOME OF SIMILAR ISSUE OF THE SAME PRODUCT (SYRINGE 20ML 18G 1-1/2IN) WHICH WERE MANUFACTURED FROM DEC 2018 TO APR 2019 FROM OTHER CUSTOMER. ROOT CAUSE: BASED ON THE TEST RESULTS OF THE COMPLAINT CASE BY COMPLAINT SAMPLES, SBDM DIDN`T FIND 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. THEREFORE, IT CAUSED THIS COMPLAINT CASE. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 20ML 18G 1-1/2IN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 20ML 18G 1-1/2IN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55299 SYRINGE 20ML 18G 1-1/2IN SYRINGE FMF BECTON DICKINSON 1904133

    Patients

    Seq Age Sex Outcome Treatment
    1