BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 21X1 RB

    MDR report key: 23312577 · Received October 16, 2025

    Report

    Report Number
    1911916-2025-00681
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 25, 2025
    Report Date
    October 27, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051656
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP IT WAS REPORTED THE NEEDLE WAS BENT OUT OF THE PLASTIC SAFETY PLACE. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 305165 AND LOT NUMBER 4212463. THE REVIEW DID NOT IDENTIFY ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE DEFECT, AND ALL QUALITY TESTS WERE WITHIN SPECIFICATION. DUE TO THE UNAVAILABILITY OF A SAMPLE FOR RETURN, A COMPREHENSIVE SAMPLE INVESTIGATION COULD NOT BE CONDUCTED. CONSEQUENTLY, THE EXACT CAUSE OF THIS INCIDENT REMAINS UNDETERMINED. SHOULD YOU ENCOUNTER ANY FURTHER ISSUES WITH OUR PRODUCT, WE WOULD APPRECIATE THE OPPORTUNITY TO PERFORM A DETAILED ANALYSIS. AT THIS TIME, NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 21X1 RB WENT THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305165, BATCH#: 4212463. RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT: (B)(4), PRODUCT: BD 21G X 1" NEEDLE 100/BOX, PRODUCT#: 15-5165-4, LOT#: 4212463. COMPLAINT: A PERITONEAL DIALYSIS (PD) REGISTER NURSE (CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT A COMPLAINT REGARDING THE PRODUCT BD 21G X 1" NEEDLE 100/BOX. SHE STATED THAT THE NEEDLE WAS BENT OUT OF THE PLASTIC SAFETY PLACE AND A STAFF MEMBER WAS POKED WITH THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2098669 BD NEEDLE 21X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 4212463 00382903051656

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown