BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOCATH 22GA X 1,00IN

    MDR report key: 12601787 · Received October 8, 2021

    Report

    Report Number
    9610048-2021-00135
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    September 10, 2021
    Report Date
    October 20, 2021
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 1131061, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED THAT THE NEEDLE HAD PIERCED THROUGH THE CATHETER TUBING CAUSING THE TUBING TO APPEAR BENT. BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. HOWEVER, THE DEVICE APPEARED TO HAVE BEEN USED INDICATING THAT THE DEVICE WAS NOT RECEIVED IN THIS CONDITION. IF THE NEEDLE HAD ALREADY PIERCED THROUGH THE CATHETER TUBING THE NEEDLE WOULD NOT HAVE BEEN ABLE TO THREAD THE CATHETER INTO THE PATIENT'S VEIN. THEREFORE, THE FAILURE WAS MOST LIKELY NOT A MANUFACTURING DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 ANGIOCATHS 22GA X 1,00IN HAD A NEEDLE THROUGH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " THE DEVIATIONS ARE CATHETER FOLDED AND NEEDLE THROUGH CATHETER. ".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1131061. MEDICAL DEVICE EXPIRATION DATE: 2026-04-30. DEVICE MANUFACTURE DATE: 2021-05-26. MEDICAL DEVICE LOT #: 1119917. MEDICAL DEVICE EXPIRATION DATE: 2026-04-30. DEVICE MANUFACTURE DATE: 2021-05-13. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 ANGIOCATHS 22GA X 1,00IN HAD A NEEDLE THROUGH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " THE DEVIATIONS ARE CATHETER FOLDED AND NEEDLE THROUGH CATHETER. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498425 ANGIOCATH 22GA X 1,00IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown