BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH IV CATHETER 20GA 1.88IN

    MDR report key: 10188333 · Received June 24, 2020

    Report

    Report Number
    2243072-2020-00943
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    May 27, 2020
    Report Date
    July 23, 2020
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    K151698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD ANGIOCATH¿ IV CATHETER 20GA 1.88IN EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE WARDS, THE PATIENT WAS FOUND TO HAVE BLOOD LEAKAGE IN THE LEFT WRIST ART INDWELLING CATHETER. AFTER TEARING OFF THE APPLICATION, BLOOD LEAKAGE WAS FOUND IN THE CATHETER, SO THE CATHETER WAS REMOVED AND PLACED AGAIN. THE PROCEDURE WENT SUCCESSFULLY. D.1. MEDICAL DEVICE BRAND NAME: BD ANGIOCATH¿ IV CATHETER 20GA 1.88IN D.1. COMMON DEVICE NAME: INTRAVASCULAR CATHETER D.2. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. D.2. MEDICAL DEVICE TYPE: FOZ D.4. MEDICAL DEVICE CATALOG #: 381137 D.4. MEDICAL DEVICE LOT #: 8355519 D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31 D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4) G.1. MANUFACTURING LOCATION: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. G.5. PMA/510(K)#: K151698 H.4. DEVICE MANUFACTURE DATE: 2019-01-24 H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. H3 : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ANGIOCATH¿ IV CATHETER 20GA 1.88IN EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE WARDS, THE PATIENT WAS FOUND TO HAVE BLOOD LEAKAGE IN THE LEFT WRIST ART INDWELLING CATHETER. AFTER TEARING OFF THE APPLICATION, BLOOD LEAKAGE WAS FOUND IN THE CATHETER, SO THE CATHETER WAS REMOVED AND PLACED AGAIN. THE PROCEDURE WENT SUCCESSFULLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ANGIOCATH¿ IV CATHETER 20GA 1.88IN EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE WARDS, THE PATIENT WAS FOUND TO HAVE BLOOD LEAKAGE IN THE LEFT WRIST ART INDWELLING CATHETER. AFTER TEARING OFF THE APPLICATION, BLOOD LEAKAGE WAS FOUND IN THE CATHETER, SO THE CATHETER WAS REMOVED AND PLACED AGAIN. THE PROCEDURE WENT SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: CUSTOMER PROVIDED AN INVALID LOT # OF 5355519. IF CLARIFYING INFORMATION IS RECEIVED LEADING TO A VALID LOT #, THIS REPORT WILL BE ADDED. 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. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD ANGIOCATH CATHETER EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE WARDS, THE PATIENT WAS FOUND TO HAVE BLOOD LEAKAGE IN THE LEFT WRIST ART INDWELLING CATHETER. AFTER TEARING OFF THE APPLICATION, BLOOD LEAKAGE WAS FOUND IN THE CATHETER, SO THE CATHETER WAS REMOVED AND PLACED AGAIN. THE PROCEDURE WENT SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655654 BD ANGIOCATH IV CATHETER 20GA 1.88IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 8355519

    Patients

    Seq Age Sex Outcome Treatment
    1 Other