BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20GX1.75IN PRO SAFETY ARTERIAL CATH PUR

    MDR report key: 9306046 · Received November 11, 2019

    Report

    Report Number
    2243072-2019-02523
    Event Type
    Malfunction
    Date Received
    November 11, 2019
    Date of Event
    October 25, 2019
    Report Date
    November 18, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES OR PHOTOS WERE RETURNED. 5 RETAINED SAMPLES FROM THE SAME LOT WERE TESTED FOR LEAKAGE. ONCE THE CATHETERS WERE INSERTED INTO THE PLASTIC PLUG, THE CAP WAS CLOSED AND THEN INSPECTED FOR LEAKAGES. NO LEAKAGE WAS FOUND. AFTER THIS FIRST CONTROL, ALL THE CAPS WERE RE-OPENED AND CLOSED. THIS FURTHER ACTION WAS PERFORMED TO VERIFY IF THE CAP DIDN¿T CLOSE THE INTERNAL LUMEN OF THE CATHETER PROPERLY AFTER A SECOND ACTIVATION. NO LEAKAGE WAS FOUND. 10 SAMPLES OF THE SAME LOT WERE SUBMITTED TO LEAKAGE TEST AS DEFINED IN THE INTERNAL PROCEDURE. NO LEAKAGE WAS FOUND THEN EITHER. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE 20GX1.75IN PRO SAFETY ARTERIAL CATH PUR HAS BEEN FOUND EXPERIENCING LEAKAGE AFTER USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE NEEDLE DOES NOT CLOSE AFTER INSERTION, AND BLOOD CONTINUES TO LEAK. LOT NUMBER: 1180114.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. 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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE 20GX1.75IN PRO SAFETY ARTERIAL CATH PUR HAS BEEN FOUND EXPERIENCING LEAKAGE AFTER USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE NEEDLE DOES NOT CLOSE AFTER INSERTION, AND BLOOD CONTINUES TO LEAK. LOT NUMBER: 1180114.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097465 20GX1.75IN PRO SAFETY ARTERIAL CATH PUR CATHETER FOZ BECTON DICKINSON 1180114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other