BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 16X1 RB

    MDR report key: 18594728 · Received January 29, 2024

    Report

    Report Number
    1911916-2024-00040
    Event Type
    Malfunction
    Date Received
    January 29, 2024
    Date of Event
    January 18, 2024
    Report Date
    February 16, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051978
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 9565462 FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS A BLACK SUBSTANCE ON THE NEEDLE. TO AID IN THE INVESTIGATION, TWO SAMPLES IN OPENED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH 10X MAGNIFICATION, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. NO FOREIGN MATTER OF ANY KIND WAS FOUND. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305197, LOT 3083045. 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. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    (B)(4) : INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL#: 305197 LOT#: 3083045. IT WAS REPORTED BY THE CUSTOMER REPORTED BLACK SUBSTANCE ON THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCT COMPLAINT-MDS BD PRECISION GLIDE NEEDLE . REF: 305197. LOT: 3083045. ISSUE: BLACK SUBSTANCE ON THE NEEDLE. DOE: (B)(6) 2024. SAMPLE AVAILABLE: YES /PLEASE OPEN TASK FOR SAMPLE RETURN KIT ONCE THIS IS ASSIGNED TO THE RCC. NO PT IMPACT. RELATED (B)(4) (CLOSED).

    Description of Event or Problem · 0

    MATERIAL#: 305197 LOT#: 3083045 IT WAS REPORTED BY THE CUSTOMER REPORTED BLACK SUBSTANCE ON THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCT COMPLAINT-MDS BD PRECISION GLIDE NEEDLE REF: (B)(4) LOT: 3083045 ISSUE: BLACK SUBSTANCE ON THE NEEDLE DOE: ON (B)(6) 2024 SAMPLE AVAILABLE: YES /PLEASE OPEN TASK FOR SAMPLE RETURN KIT ONCE THIS IS ASSIGNED TO THE RCC NO PT IMPACT RELATED (B)(4) (CLOSED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824631 NEEDLE 16X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3083045 30382903051978

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown