BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH PICC D/L 20GA (2.6F) 0.90MM X 60CM

    MDR report key: 16904231 · Received May 10, 2023

    Report

    Report Number
    0001625425-2023-01051
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    March 30, 2023
    Report Date
    August 29, 2023
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    PMA / PMN Number
    K091670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO SIMILAR CONCERNS WERE FOUND. AFTER THREE NOTIFICATIONS, THERE HAS BEEN NO SAMPLE RETURNED FOR REVIEW. ADDITIONALLY, NO PHOTOGRAPHIC OR VISUAL EVIDENCE OF ANY KIND WAS PROVIDED WHICH WOULD HAVE ALLOWED FOR THE ALLEGATION TO BE REVIEWED. HOWEVER, DUE TO THE NUMBER OF COMPLAINTS REGARDING THIS ISSUE WITH THIS PART NUMBER, THIS COMPLAINT WILL BE CONFIRMED FOR ONE DEVICE. SEVERAL COMPLAINTS FOR THIS PART NUMBER HAVE PREVIOUSLY BEEN RECEIVED REGARDING A CRACKED HUB RESULTING IN LEAKAGE, AND CAPA 2021-039 WAS INITIATED TO ADDRESS THIS ISSUE. THE CAPA IS CURRENTLY IN THE IMPLEMENTATION PHASE AND WILL EVALUATE THE CORRECTIVE ACTION IMPLEMENTATION FOR EFFECTIVENESS TO PREVENT A RECURRENCE OF THIS ISSUE.

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RECEIVED AND REVIEWED.

    Description of Event or Problem · 0

    ¿DATE OF INSERTION (B)(6)2023¿ ¿AT 0507 MAINTENANCE IVF STARTED AT 19ML/HR THROUGH THE BLUE CONNECTION OF THE PICC GIVEN NPO STATUS. AT 0520 BLUE LUMEN NOTED TO BE LEAKING AND CONNECTION AT QUAD FUSE WOULD NOT TIGHTEN (SPINNING PART KEPT SPINNING INSTEAD OF TIGHTENING). QUAD-FUSE CHANGED ¿ CONTINUED TO LEAK. BEFORE CONNECTING TRI-FUSE, HUB OF BLUE LUMEN NOTED TO BE DAMAGED ¿ MD NOTIFIED. PIV PLACED TO CONTINUE IVFS. PICC REMOVED ON NEXT SHIFT.¿ ¿HARM NOT SIGNIFICANT, PLACEMENT OF MULTIPLE PIV AND PICCS.¿

    Description of Event or Problem · 0

    ¿DATE OF INSERTION (B)(6) 2023¿. ¿AT 0507 MAINTENANCE IVF STARTED AT 19ML/HR THROUGH THE BLUE CONNECTION OF THE PICC GIVEN NPO STATUS. AT 0520 BLUE LUMEN NOTED TO BE LEAKING AND CONNECTION AT QUAD FUSE WOULD NOT TIGHTEN (SPINNING PART KEPT SPINNING INSTEAD OF TIGHTENING). QUAD-FUSE CHANGED ¿ CONTINUED TO LEAK. BEFORE CONNECTING TRI-FUSE, HUB OF BLUE LUMEN NOTED TO BE DAMAGED ¿ MD NOTIFIED. PIV PLACED TO CONTINUE IVFS. PICC REMOVED ON NEXT SHIFT.¿ ¿HARM NOT SIGNIFICANT, PLACEMENT OF MULTIPLE PIV AND PICCS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590136 L-CATH PICC D/L 20GA (2.6F) 0.90MM X 60CM L-CATH PICC LJS ARGON MEDICAL DEVICES 384466 11469774

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R