BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 17844600 · Received September 29, 2023

    Report

    Report Number
    1911916-2023-00709
    Event Type
    Malfunction
    Date Received
    September 29, 2023
    Date of Event
    August 10, 2023
    Report Date
    September 14, 2023
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMI
    UDI-DI
    00382903016433
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. IT WAS REPORTED PIECES HAVE DEFORMED CANNULA TIPS. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A BENT NEEDLE WITH A FLAT TIP. THE CONDITIONS OF THE NEEDLE SHOWN IN THE PHOTOS DOES NOT REPRESENT HOW THE UNIT LEAVE THE MANUFACTURING SITE. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301643, LOT 2200730. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. TO PROVIDE A PROBABLE ROOT CAUSE, THE PHYSICAL SAMPLE ANALYSIS WOULD BE REQUIRED. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES WERE CRACKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: WE WANT TO INFORM YOU OF THE FOLLOWING DEVIATION IDENTIFIED DURING PROCESSING OF LOT 2200730 OF MATERIAL 301643 OBSERVED WITH DAMAGED TIPS. DESCRIPTION OF EVENT: ON (B)(6) 2023, DURING THE QC VISUAL INSPECTION, QC TECHNICIAN FOUND 2 OF 50 PIECES (NORMAL INSPECTION) TO HAVE DEFORMED CANNULA TIPS. NON-CONFORMANCES WERE CONFIRMED BY LEAD QC TECHNICIANS. THIS PRODUCTION BATCH USED COMPONENT BATCH 15CR8X OF MATERIAL 300030262, CANNULA, BLUNT, 27 GA X 1 (05-8020), WHICH IS RECEIVED FROM BECTON DICKINSON AND COMPANY (SUPPLIER# (B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271689 BD CONVENTIONAL NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND COMPANY 2200730 00382903016433

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown