BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE S2 10ML 22GA 1-1/4IN BD CHINA

    MDR report key: 15376062 · Received September 8, 2022

    Report

    Report Number
    3002682307-2022-00232
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    July 14, 2022
    Report Date
    September 19, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ; A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301945 AND LOT NUMBER 2110129. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR THIS INCIDENT, TWENTY RETAINED SAMPLES WERE OBTAINED FOR EVALUATION; HOWEVER, NO SIGNS OF DEFECT WERE FOUND IN THE RETAINED SAMPLES. AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. THE MATERIAL USED TO MANUFACTURE THE DISCARDIT SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLY MACHINES HAVE AN IN-LINE DETECTION SYSTEM THAT INSPECTS ALL PRODUCT AND AUTOMATICALLY REJECTS ANY DAMAGES IDENTIFIED. BASED ON THESE PREVENTIVE MEASURES, WE BELIEVE IT IS POSSIBLE THAT THE REPORTED INCIDENT RESULTED FROM A BLOCKAGE DURING THE BARREL FEEDING PROCESS. AFTER THAT, THE DAMAGED TIP OF THE SYRINGE WENT UNDETECTED DURING ASSEMBLY AND RESULTED IN BREAKAGE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE S2 10ML 22GA 1-1/4IN BD CHINA THE TIP OF THE SYRINGE BROKE OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: (B)(6) 2022 DURING THE DOSING PROCESS, THE NURSE TORE THE OUTER PACKAGING OF THE SYRINGE AND FOUND THAT THE TIP OF BARREL OF THE SYRINGE WAS BROKEN AND COULD NOT BE USED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE S2 10ML 22GA 1-1/4IN BD CHINA THE TIP OF THE SYRINGE BROKE OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: 2022.7.14 DURING THE DOSING PROCESS, THE NURSE TORE THE OUTER PACKAGING OF THE SYRINGE AND FOUND THAT THE TIP OF BARREL OF THE SYRINGE WAS BROKEN AND COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2096120 BD SYRINGE S2 10ML 22GA 1-1/4IN BD CHINA PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110129

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown