BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 7117299 · Received December 14, 2017

    Report

    Report Number
    1911916-2017-00361
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    November 22, 2017
    Report Date
    January 10, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051977
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FDA NOTIFIED?: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON NOV-2017 VIA MEDWATCH # (B)(4). BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. THE FOREIGN MATTER WAS IDENTIFIED TO BE GREASE IN A NON-FLUID PATH AREA. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION - COMPLAINT CONFIRMED. POSSIBLE ROOT CAUSES - PICKED UP GREASE DURING TRANSFER FROM THE MOLD PRESS TO THE CONTAINER. CAME IN CONTACT WITH GREASE DURING ASSEMBLY. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION OF INITIAL MDR MEDICAL DEVICE TYPE FROM: FOZ TO: FMI.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE HAD FOREIGN MATTER FOUND IN THE HUB. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897349 BD PRECISIONGLIDE¿ NEEDLE INTERVASCULAR CATHETER FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 7200966 00382903051977

    Patients

    Seq Age Sex Outcome Treatment
    1 Other