BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHENA 22GX1.00IN WINGED BC

    MDR report key: 8691486 · Received June 12, 2019

    Report

    Report Number
    8041187-2019-00444
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 28, 2019
    Report Date
    September 19, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903868131
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLE WAS RETURNED FOR INVESTIGATION. FROM THE PICTURES, THE ADAPTER WAS REMOVED, HOWEVER THE TIP SHIELD REMAINED IN THE NEEDLE HUB. SAFETY SHIELD ACTIVATION FAILURE WAS OBSERVED. DHR REVIEW WAS PERFORMED FOR THE REPORTED BATCH: 8269112 AND ITS AN BATCH: 826915. NO SIMILAR QN WAS RAISED. NO ABNORMALITY OBSERVED IN THAT COULD HAVE INFLUENCED THE ISSUE. CONCLUSION: THE PHOTOS SHOW THE REPORTED NON-CONFORMANCE. THE COMPLAINT IS CONFIRMED, AND PRODUCT IS OUT OF SPECIFICATION. THE ROOT CAUSE COULD NOT BE CONFIRMED AS THE SAMPLE WAS NOT RETURNED FOR INVESTIGATION CAPA#: 821876 HAS BEEN RAISED TO ADDRESS SAFETY ACTIVATION FAILURE ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHENA 22GX1.00IN WINGED BC SAFETY SHIELD REMAINED STUCK IN THE TRANSPARENT SLEEVE DURING USE, LEAVING THE NEEDLE EXPOSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: AS PART OF THE CATHENA CATHETER TESTS, I ENCOUNTERED A PROBLEM DURING THE SAFETY OF THE NEEDLE. THE WHITE PART WHICH IS SUPPOSED TO COVER THE SHARP PART OF THE NEEDLE, REMAINED STUCK IN THE TRANSPARENT SLEEVE DURING THE SECURITY OF THE NEEDLE. LEAVING THE SHARP PART OF THE NEEDLE COMPLETELY ACCESSIBLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHENA 22GX1.00IN WINGED BC SAFETY SHIELD REMAINED STUCK IN THE TRANSPARENT SLEEVE DURING USE, LEAVING THE NEEDLE EXPOSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: AS PART OF THE CATHENA CATHETER TESTS, I ENCOUNTERED A PROBLEM DURING THE SAFETY OF THE NEEDLE. THE WHITE PART WHICH IS SUPPOSED TO COVER THE SHARP PART OF THE NEEDLE, REMAINED STUCK IN THE TRANSPARENT SLEEVE DURING THE SECURITY OF THE NEEDLE. LEAVING THE SHARP PART OF THE NEEDLE COMPLETELY ACCESSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487437 CATHENA 22GX1.00IN WINGED BC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8269112 00382903868131

    Patients

    Seq Age Sex Outcome Treatment
    1 Other