BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24G X 0.75IN (0.7 X 19 MM) ANGIOCATH PLUS

    MDR report key: 8945943 · Received August 29, 2019

    Report

    Report Number
    8041187-2019-00690
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 13, 2019
    Report Date
    October 22, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SIX ACTUAL SAMPLES WITH OPEN PACKAGING WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THE SAMPLES RECEIVED, NO ABNORMALITIES WERE IDENTIFIED; THEREFORE, THE FAILURE COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 24G X 0.75IN (0.7 X 19 MM) ANGIOCATH PLUS EXPERIENCED A CATHETER THAT WAS DEFECTIVE/DAMAGED/DEFORMED. THE PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FLYING CATHETER. CATHETER ADHESION IS SO WEAK, WHEN CATHETER'S COVER OFTEN, CATHETER IS EASILY COME OFF.

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8265325. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-09-22. MEDICAL DEVICE LOT #: 9081576. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-03-22.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 24G X 0.75IN (0.7 X 19 MM) ANGIOCATH PLUS EXPERIENCED A CATHETER THAT WAS DEFECTIVE/DAMAGED/DEFORMED. THE PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FLYING CATHETER. CATHETER ADHESION IS SO WEAK, WHEN CATHETER'S COVER OFTEN, CATHETER IS EASILY COME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740871 24G X 0.75IN (0.7 X 19 MM) ANGIOCATH PLUS INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other