BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ STERILE HYPODERMIC NEEDLE

    MDR report key: 7059752 · Received November 27, 2017

    Report

    Report Number
    1911916-2017-00311
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 30, 2017
    Report Date
    December 8, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903051954
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ONE USED SAMPLE WAS RETURNED TO THE COLUMBUS PLANT FOR EVALUATION. THERE IS A LONG FIBER ON THE CANNULA THEREFORE FAILURE MODE IS CONFIRMED. DUE TO THE FACT THAT THE NEEDLE HAS BEEN USED, WE ARE UNABLE TO CONFIRM THE SOURCE OF THE FIBER ON THE CANNULA. ASSEMBLY BATCH 7060628 HAD 126 VISUAL INSPECTIONS PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED 17 TIMES DURING THE PRODUCTION OF THIS BATCH. ALL CLEANING WAS DONE PER PROCEDURE. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. QN REVIEW: NO NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. DHR REVIEW: ASSEMBLY BATCH 7060628 HAD 126 VISUAL INSPECTIONS PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED 17 TIMES DURING THE PRODUCTION OF THIS BATCH. ALL CLEANING WAS DONE PER (B)(4). INVESTIGATION RESULTS: ONE USED SAMPLE WAS RETURNED. THERE IS A LONG FIBER ON THE CANNULA. POSSIBLE ROOT CAUSE: DUE TO THE FACT THAT THE NEEDLE HAS BEEN USED, WE ARE UNABLE TO CONFIRM THE SOURCE OF THE FIBER ON THE CANNULA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE 18 G X 1 IN. BD" GENERAL USE STERILE HYPODERMIC NEEDLE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838828 BD¿ STERILE HYPODERMIC NEEDLE NEEDLE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 7086712 30382903051954

    Patients

    Seq Age Sex Outcome Treatment
    1 Other