BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 11346619 · Received February 18, 2021

    Report

    Report Number
    9610847-2021-00075
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 22, 2021
    Report Date
    March 23, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR VALID LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. DHR COULD NOT BE PERFORMED DUE TO NO VALID LOT#. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM 20 GA 1.25 IN (1.1 X 32 MM) (W/ BD CONNECTA AND CAP) EXPERIENCED DIFFICULT SAFETY MECHANISM/NEEDLE DISENGAGEMENT (REMOVAL). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN I STUCK THE PATIENT, THE NEEDLE WOULD NOT GET OUT. IT CAN BE REVERSED SO FAR UNTIL IT WOULD NORMALLY "LOOSEN" BUT THEN STOPS AND CAN NOT BE DETACHED FROM PVK, EVEN THOUGH I PULLED VERY HARD.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE BRAND NAME: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM 20 GA 1.25 IN. (1.1 X 32 MM) (W/ BD CONNECTA AND CAP) DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE LOT #: AN INVALID LOT # OF 19157 WAS PROVIDED BY THE INITIAL REPORTER A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM 20 GA 1.25 IN (1.1 X 32 MM) (W/ BD CONNECTA AND CAP) EXPERIENCED DIFFICULT SAFETY MECHANISM/NEEDLE DISENGAGEMENT (REMOVAL). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN I STUCK THE PATIENT, THE NEEDLE WOULD NOT GET OUT. IT CAN BE REVERSED SO FAR UNTIL IT WOULD NORMALLY "LOOSEN" BUT THEN STOPS AND CAN NOT BE DETACHED FROM PVK, EVEN THOUGH I PULLED VERY HARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239589 SEE H10 INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1