BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 RB

    MDR report key: 19792453 · Received July 22, 2024

    Report

    Report Number
    1911916-2024-00528
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    July 15, 2024
    Report Date
    August 6, 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 FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS A WHITE SPOT ON THE NEEDLE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE NEEDLE ASSEMBLY HAS AN EPOXY DRIP OVER ON THE NEEDLE. THE TWO PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR DURING THE ASSEMBLY PROCESS IF THERE WAS A JAM AT THE CANNULATOR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305196, LOT 3024120. 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. THE SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. 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 IS CONFIRMED.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL# 305196. BATCH# 3024120. IT WAS REPORTED BY CUSTOMER THAT NURSE OPENED NEEDLE FROM PACKAGE, NOTICED WHITE SPOT ON NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE RECEIVED THE FOLLOWING PRODUCT COMPLAINT FROM OUR SAME DAY TREATMENT UNIT: PRODUCT: 305196. LOT: 3024120. DATE OF INCIDENT: JULY 15, 2024. PATIENT HARM: NO. ISSUE: NURSE OPENED NEEDLE FROM PACKAGE, NOTICED WHITE SPOT ON NEEDLE. NEEDLE WAS NOT USED. THE SPOT APPEARS TO BE A PIECE OF THE ADHESIVE FROM THE BASE WHERE THE METAL IS CONNECTED. IT IS LOOSE AND WAS AGAINST THE PASTIC COVER WHEN I RECEIVED.

    Description of Event or Problem · 0

    MATERIAL# 305196. BATCH# 3024120. IT WAS REPORTED BY CUSTOMER THAT NURSE OPENED NEEDLE FROM PACKAGE, NOTICED WHITE SPOT ON NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE RECEIVED THE FOLLOWING PRODUCT COMPLAINT FROM OUR SAME DAY TREATMENT UNIT: PRODUCT: 305196. LOT: 3024120. DATE OF INCIDENT: (B)(6) 2024. PATIENT HARM: NO. ISSUE: NURSE OPENED NEEDLE FROM PACKAGE, NOTICED WHITE SPOT ON NEEDLE. NEEDLE WAS NOT USED. THE SPOT APPEARS TO BE A PIECE OF THE ADHESIVE FROM THE BASE WHERE THE METAL IS CONNECTED. IT IS LOOSE AND WAS AGAINST THE PASTIC COVER WHEN I RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737505 NEEDLE 18X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3024120 30382903051961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown