BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 16X1 RB

    MDR report key: 19475823 · Received June 6, 2024

    Report

    Report Number
    1911916-2024-00397
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    May 14, 2024
    Report Date
    July 12, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051978
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE NEEDLES WERE BENT AND BROKEN. TO AID IN THE INVESTIGATION, THIRTEEN HUNDRED SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. TWO HUNDRED SAMPLES WERE RANDOMLY SELECTED FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305197, LOT 3320201. 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 RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL# 305197 BATCH# 3320201 IT WAS REPORTED BY CUSTOMER THAT THE NEEDLES WERE BENT AND BROKEN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED WE HAVE PRODUCT THAT IS NON-CONFORMING, UNDER COMPLAINT NUMBER (B)(4). LOT 3320201 IS DEFECTIVE. BENT AND BROKEN NEEDLES. WE WOULD LIKE TO RETURN ALL ITEMS UNDER THIS LOT NUMBER FOR CREDIT. WE HAVE PRODUCT IN OUR JACKSONVILLE, FL LOCATION: VENDOR ITEM: 305197 LOT #: 3320201 QTY: (B)(4).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL# 305197, BATCH# 3320201. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLES WERE BENT AND BROKEN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE PRODUCT THAT IS NON-CONFORMING, UNDER COMPLAINT NUMBER 120784. LOT 3320201 IS DEFECTIVE. BENT AND BROKEN NEEDLES. WE WOULD LIKE TO RETURN ALL ITEMS UNDER THIS LOT NUMBER FOR CREDIT. WE HAVE PRODUCT IN OUR JACKSONVILLE, FL LOCATION: VENDOR ITEM: 305197, LOT #: 3320201, QTY: (B)(4) EACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7088 NEEDLE 16X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3320201 30382903051978

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown