BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 18X1-1/2 RB TW

    MDR report key: 18014942 · Received October 26, 2023

    Report

    Report Number
    3002682307-2023-00316
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    August 31, 2023
    Report Date
    December 18, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903032624
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBER 230601. 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. THE RETAINED SAMPLES WERE VISUALLY EXAMINED AND NO DEFECTS WERE IDENTIFIED. THE SAMPLES WERE THEN USED TO PUNCTURE A TEST VIAL AND RE-EXAMINED UNDER MICROSCOPE WITH NO ISSUES DETECTED. ALTHOUGH WE WERE UNABLE TO REPLICATE THE REPORTED ISSUE, WE UNDERSTAND THAT AN INCIDENT OR CORING WHICH LED TO CLOGGING MOST LIKELY TOOK PLACE. MATERIAL 303262 HAS BEEN CREATED WITH A REGULAR BEVEL IN COMPARISON TO MATERIAL 304622 WHICH HAD A SHORT BEVEL. THE REGULAR BEVEL OF MATERIAL 303262 SHOULD PIERCE THE VIAL BETWEEN 45-60 DEGREES TO MINIMIZE THE RISK OF CORING. 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. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE 18X1-1/2 RB TW CLOGGED AFTER INITIAL ASPIRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIFFICULTY USING TROCARS. NO PROBLEM TO ASPIRATE AMPOULES BUT THEN DIFFICULTY TO REINJECT. REINJECTION INTO SOLUTIONS. PROBLEM SOLVED BY CHANGING TROCAR. PROBLEM SOLVED BY CHANGING TROCAR. THE INCRIMINATED DEVICES WERE NOT KEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152009 BD NEEDLE 18X1-1/2 RB TW NEEDLE HYPODERMIC FMI BECTON DICKINSON, S.A. 230601 00382903032624

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown