BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 2-PIECE SYRINGE

    MDR report key: 16653046 · Received March 30, 2023

    Report

    Report Number
    3002682307-2023-00088
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 13, 2023
    Report Date
    June 5, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309110 AND LOT NUMBER 2211257. 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 FOR REVIEW; HOWEVER, NONE OF THE RETAINED SAMPLES DISPLAYED ANY SIGNS OF LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT II 2-PIECE SYRINGE EXPERIENCED (SHORT DESCRIPTION OF EVENT) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DURING THE WITHDRAWAL OF THE TREATMENT WITH THE SYRINGE, THE LATTER PASSED BETWEEN THE JOINT OF THE SYRINGE AND THE PLUNGER AND THE PRODUCT FLOWED OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT II 2-PIECE SYRINGE EXPERIENCED (SHORT DESCRIPTION OF EVENT) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DURING THE WITHDRAWAL OF THE TREATMENT WITH THE SYRINGE, THE LATTER PASSED BETWEEN THE JOINT OF THE SYRINGE AND THE PLUNGER AND THE PRODUCT FLOWED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580097 BD DISCARDIT II 2-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2211257

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown