BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ NEEDLE

    MDR report key: 17281447 · Received July 7, 2023

    Report

    Report Number
    3002682307-2023-00186
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 19, 2023
    Report Date
    December 6, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903031290
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) UNUSED NEEDLES BELONGING TO LOT NUMBER 230204 WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE (1) FULL SYRINGE OF MEDICATION WAS PROVIDED AS WELL. UPON EXAMINATION OF THE SYRINGE, NO PLASTIC PARTICLES WERE OBSERVED WITHIN THE SYRINGE. THE NEEDLE SAMPLES WERE TESTED WITH A LAB VIAL (PLASTIC STOPPER) AND NO DIFFICULTIES WERE IDENTIFIED. THE NEEDLES WERE THEN MICROSCOPICALLY EXAMINED AND NO PARTICLES OR SIGNS OF STOPPER FRAGMENTATION WERE IDENTIFIED; THE BEVELS WERE FOUND TO BE WELL FORMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 230204. 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. BASED ON THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT CORING RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA. IT IS POSSIBLE THAT THE STOPPER CONDITIONS (ASK YOUR SUPPLIER FOR MATERIAL CHANGES AS WELL AS RECOMMENDATIONS OF STORAGE IN CASE HUMIDITY AND/OR TEMPERATURE AFFECTS THE FRAGMENTATION OF THE RUBBER) AND THE HANDLING OF THE PRODUCT HAD A ROLE IN THE REPORTED INCIDENT.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H3. 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 · 0

    IT WAS REPORTED THAT AN UNPECIFIED BD¿ NEEDLE WAS CORING WHEN USED. THE FOLLOWING WAS RECIEVED BY THE INITIAL REPORTER: WHILE RETRIEVING AN AMPULE OF ROCURONIUM WITH A BLUNT COLLECTION NEEDLE, THE RUBBER MEMBRANE WAS PUNCTURED. THE INCIDENT WAS NOTICED AND THE DRUG WAS NOT ADMINISTERED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2031180 UNSPECIFIED BD¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 230204 00382903031290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown