BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 RB

    MDR report key: 18895762 · Received March 13, 2024

    Report

    Report Number
    1911916-2024-00182
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    February 29, 2024
    Report Date
    March 14, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051961
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. IT WAS REPORTED THE NEEDLE HAD A FOREIGN OBJECT. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A NEEDLE ASSEMBLY WITH THE PLASTIC SHIELD PARTIALLY REMOVED. THE NEEDLE HAS AN EPOXY DRIP OVER ON THE NEEDLE HUB. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM AT THE CANNULATOR INDUCING THE EPOXY DRIP OVER ON THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305196, LOT 3055139. 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. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 1. THE CUSTOMER STILL HAS THE PRODUCT IN THEIR POSSESSION. 2. THE PHYSICIAN WAS ABOUT TO ADMINISTER AN INJECTION BUT NOTICED THE ISSUE BEFORE PROCEEDING WITH THE PATIENT. 3. THERE WAS NO IMPACT ON THE PATIENT AS THE PROBLEM WAS IDENTIFIED BEFORE THE PROCEDURE TOOK PLACE. MATERIAL#: 305196 ,BATCH#: 3055139. IT WAS REPORTED BY CUSTOMER THAT WE RECEIVED THE NEEDLE WITH A FOREIGN OBJECT INSIDE, PHOTO PROVIDED AS EVIDENCE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE RECEIVED THE NEEDLE WITH A FOREIGN OBJECT INSIDE, PHOTO PROVIDED AS EVIDENCE. ITEM#305196. LOT#3055139.

    Description of Event or Problem · 0

    MATERIAL#: 305196, BATCH#: 3055139. IT WAS REPORTED BY CUSTOMER THAT WE RECEIVED THE NEEDLE WITH A FOREIGN OBJECT INSIDE, PHOTO PROVIDED AS EVIDENCE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE RECEIVED THE NEEDLE WITH A FOREIGN OBJECT INSIDE, PHOTO PROVIDED AS EVIDENCE. ITEM#305196, LOT#3055139.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162832 NEEDLE 18X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3055139 30382903051961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown