BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CATHENA¿ BC STRAIGHT CATHETER

    MDR report key: 8348629 · Received February 18, 2019

    Report

    Report Number
    8041187-2019-00155
    Event Type
    Malfunction
    Date Received
    February 18, 2019
    Date of Event
    January 25, 2019
    Report Date
    May 6, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    LJS
    UDI-DI
    00382903868049
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ¿ THE RETURNED SAMPLE WAS NOT DECONTAMINATED BY VENDOR 1 SAMPLE WAS RETURNED WITHOUT COVER AND ADAPTER FOR INVESTIGATION IT WAS OBSERVED THAT THE ADAPTER HAD BEEN REMOVED, HOWEVER THE TIP SHIELD IS REMAINED IN THE HUB. SAFETY ACTIVATION FAILURE WAS OBSERVED. THE ADAPTER HAD BEEN REMOVED BUT THE TIP SHIELD IS REMAINED IN THE HUB THE PHOTOS AND ACTUAL SAMPLE RECEIVED SHOW THE REPORTED NON-CONFORMANCE. THE COMPLAINT IS CONFIRMED AND PRODUCT IS OUT OF SPECIFICATION. THE PROBABLE ROOT CAUSE COULD BE DUE THE DAMAGED ADAPTER. HOWEVER, THE ROOT CAUSE COULD NOT BE CONFIRMED AS THE ADAPTER WAS NOT RETURNED FOR INVESTIGATION. CAPA#821876 WAS INITIATED. DHR WAS REVIEWED AND NO SIMILAR QN WAS RAISED ALONG WITH NO ABNORMALITY OBSERVED THAT COULD HAVE INFLUENCED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD CATHENA¿ BC STRAIGHT CATHETER THERE WAS AN ISSUE WITH SAFETY MECHANISM FAILED TO ENGAGE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD CATHENA BC STRAIGHT CATHETER THERE WAS AN ISSUE WITH SAFETY MECHANISM FAILED TO ENGAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139952 BD CATHENA¿ BC STRAIGHT CATHETER INTRAVASCULAR CATHETER LJS BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN 00382903868049

    Patients

    Seq Age Sex Outcome Treatment
    1 Other