BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 RB

    MDR report key: 20389576 · Received October 7, 2024

    Report

    Report Number
    1911916-2024-00719
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    August 27, 2024
    Report Date
    October 14, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051961
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 NEEDLE HAS CONTAMINATION AT THE NEEDLE HUB. TO AID IN THE INVESTIGATION, ONE SAMPLE IN A SEALED PACKAGING BLISTER AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. FIRST WITH 10X MAGNIFICATION AND THEN WITH 30X MAGNIFICATION. NO DEFECTS, IMPERFECTIONS OR FOREIGN MATTER OF ANY KIND WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305196, LOT 4031358. 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 REPORTED FOR THIS LOT. 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: UNKNOWN BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT HAVE AN 18G NEEDLE WHICH HAS CONTAMINATION AT THE NEEDLE HUB WHERE IT CONNECTS TO A SYRINGE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NO INJURY REPORTED NEEDLE WAS NOT USED MATERIAL: 305196 BATCH#: 4031358. IT WAS REPORTED BY THE CUSTOMER THAT HAVE AN 18G NEEDLE WHICH HAS CONTAMINATION AT THE NEEDLE HUB WHERE IT CONNECTS TO A SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE AN 18G NEEDLE WHICH HAS CONTAMINATION AT THE NEEDLE HUB WHERE IT CONNECTS TO A SYRINGE. NEEDLE IS IN ORIGINAL WRAPPER AND CAN SEND OUT FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2546650 NEEDLE 18X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4031358 30382903051961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown