BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE

    MDR report key: 17492758 · Received August 9, 2023

    Report

    Report Number
    3002682307-2023-00241
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    July 24, 2023
    Report Date
    May 28, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903010011
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD HAS BEEN UPDATED DUE TO CORRECTIONS: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHILE USING BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE THE NEEDLE SEPARATED FROM THE SYRINGE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301001 AND LOT NUMBER 2212505. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY. HOWEVER, THE RETAINED SAMPLES DID NOT SHOW ANY SIGNS OF DEFECT UPON EVALUATION. ALTHOUGH NO ISSUES WERE DETECTED, IT IS POSSIBLE THAT THE REPORTED INCIDENT RESULTED FROM DAMAGE TO THE BARREL TIP, WHICH COULD OCCUR DURING THE MANUFACTURING PROCESS OR WITHIN ASSEMBLY. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE THE NEEDLE PULLED FROM THE HUB. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE USING THE DISCARDIT, STAFFS FIND DIFFICULTY TO ASPIRATE THE BLOOD AND MEDICATIONS, FINDING BUBBLES IN THE SYRINGE AND NEEDLE COMING OUT OF THE SYRINGE WHILE RECONSTITUTING THE MEDICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE THE NEEDLE SEPARATED FROM THE SYRINGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE USING THE DISCARDIT, STAFFS FIND DIFFICULTY TO ASPIRATE THE BLOOD AND MEDICATIONS, FINDING BUBBLES IN THE SYRINGE AND NEEDLE COMING OUT OF THE SYRINGE WHILE RECONSTITUTING THE MEDICATION.

    Description of Event or Problem · 0

    ON (B)(6) 2023 1. THERE IS TOTAL 3 ISSUES, PLEASE PROVIDE AFFECTED QUANTITY FOR EACH ISSUE AFFECTED QUANTITY IS NOT DETERMINED. 2. PLEASE PROVIDE DATE OF OCCURRENCE AS PER THE STAFFS, THERE WERE MULTIPLE OCCURRENCES HAPPENED DURING THE FIRST AND SECOND WEEK OF JULY. 3. WHAT IS PATIENT CURRENT CONDITION? ANY SERIOUS INJURY? NO SERIOUS ISSUES WITH THE PATIENT. 4. ANY MEDICAL INTERVENTION PROVIDED? NO 5. WERE THERE AIR BUBBLES ASSOCIATED WITH THE LEAKAGE? NO 6. ANY EXPOSURE TO BLOOD? UNCERTAIN 7. ANY NEEDLE STICK INJURY? NO 8. ANY PICTURE/VIDEO? NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689510 BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2212505 00382903010011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown