BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 2-PIECE SYRINGE

    MDR report key: 16570022 · Received March 18, 2023

    Report

    Report Number
    3002682307-2023-00067
    Event Type
    Malfunction
    Date Received
    March 18, 2023
    Date of Event
    February 24, 2023
    Report Date
    May 15, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 28-APR-2023 . H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309110 AND BATCH NUMBER 2212156. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, LEAKAGE WAS CLEARLY IDENTIFIED. IT HAS BEEN DETERMINED THAT THE LEAKAGE RESULTED FROM DAMAGE TO THE PLUNGER COMPONENT. THIS TYPE OF DAMAGE MAY BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR WITHIN THE PLUNGER ASSEMBLY MACHINE.

    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: WHEN INJECTING SALINE INTO THE PATIENT'S VVP, SALINE LEAKED FROM THE BODY OF THE SYRINGE TOWARDS THE PLUNGER. WHEN PRESSING TO INJECT, THE SALINE ESCAPES THROUGH THE PLUNGER (THUS IN THE OPPOSITE DIRECTION INTENDED) INSTEAD OF GOING TO 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: WHEN INJECTING SALINE INTO THE PATIENT'S VVP, SALINE LEAKED FROM THE BODY OF THE SYRINGE TOWARDS THE PLUNGER. WHEN PRESSING TO INJECT, THE SALINE ESCAPES THROUGH THE PLUNGER (THUS IN THE OPPOSITE DIRECTION INTENDED) INSTEAD OF GOING TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999207 BD DISCARDIT II 2-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2212156 00382903091102

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female