BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE BLUNT FILL

    MDR report key: 8475276 · Received April 2, 2019

    Report

    Report Number
    1911916-2019-00343
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 15, 2019
    Report Date
    April 17, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION / DEVICE EVALUATION: D.4. MEDICAL DEVICE LOT #: 8173882. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. H.4. DEVICE MANUFACTURE DATE: 2018-06-22. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEW DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE BROKEN FOR LOT #8173882 ITEM #305180. RELATED COMPLAINT: (B)(4). INVESTIGATION CONCLUSION: NO SAMPLES OR PHOTOS WERE RECEIVED; THEREFORE, SAMPLE ANALYSIS COULD NOT BE PERFORMED AND THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED NOR COULD THIS SYMPTOM BE CORRELATED WITH A POTENTIAL CAUSE LINKED TO THE BD PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD¿ NEEDLE BLUNT FILL WAS BROKEN IN HALF WHEN PUNCTURING THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ I WILL BE FILLING OUT ANOTHER CONCERN FORM, HAVE ANOTHER BLUNT FILL NEEDLE BROUGHT TO ME BY ANETHSIA, THE PRODUCT BROKE IN HALF AFTER BEING LUER LOCKED INTO THE SYRINGE, AS SHE PUNCTURED INTO A VIAL THE TIP SNAPPED OFF. ¿

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD¿ NEEDLE BLUNT FILL WAS BROKEN IN HALF WHEN PUNCTURING THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ I WILL BE FILLING OUT ANOTHER CONCERN FORM, HAVE ANOTHER BLUNT FILL NEEDLE BROUGHT TO ME BY ANESTHESIA, THE PRODUCT BROKE IN HALF AFTER BEING LUER LOCKED INTO THE SYRINGE, AS SHE PUNCTURED INTO A VIAL THE TIP SNAPPED OFF. ¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269589 BD¿ NEEDLE BLUNT FILL BLUNT NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 8173882 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other