BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 2-PIECE SYRINGE

    MDR report key: 17417759 · Received July 28, 2023

    Report

    Report Number
    3002682307-2023-00214
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    July 6, 2023
    Report Date
    October 12, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903091102
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309110 AND LOT NUMBER 2211103. 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 RETURN, TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY. UPON REVIEW, THE RETAINED SAMPLES DID NOT DISPLAY ANY SIGNS OF LEAKAGE. BASED ON THE PROVIDED FEEDBACK, IT IS POSSIBLE THAT THE REPORTED LEAKAGE RESULTED FROM DAMAGE IN THE PLUNGER COMPONENT. IF THIS INCIDENT WERE TO REOCCUR, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW THE AFFECTED SAMPLE.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. 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 · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT II 2-PIECE SYRINGE LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: A NURSE REPORTED A PROBLEM DURING AN INJECTION WITH A 10ML BD DISCARDT II SYRINGE. THERE WAS A PARTIAL LEAK OF PRODUCT FROM THE PLUNGER WHILE INJECTING THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT II 2-PIECE SYRINGE LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: A NURSE REPORTED A PROBLEM DURING AN INJECTION WITH A 10ML BD DISCARDT II SYRINGE. THERE WAS A PARTIAL LEAK OF PRODUCT FROM THE PLUNGER WHILE INJECTING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814974 BD DISCARDIT II 2-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2211103 00382903091102

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown