BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM

    MDR report key: 18937730 · Received March 19, 2024

    Report

    Report Number
    0001625425-2024-00969
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    January 30, 2024
    Report Date
    August 31, 2024
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    UDI-DI
    00886333209934
    PMA / PMN Number
    K091670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED FOR THE PROVIDED LOT, AND NO SIMILAR CONCERNS WERE FOUND. AFTER THREE NOTIFICATIONS, THERE HAS BEEN NO SAMPLE RETURNED FOR REVIEW. THERE HAS BEEN NO VISUAL EVIDENCE PROVIDED THAT WOULD SUPPORT THE ALLEGED ALLEGATION. WITHOUT SUCH EVIDENCE, THIS COMPLAINT COULD NOT BE CONFIRMED AND DETERMINING A DEFINITE ROOT CAUSE AND CORRECTIVE ACTION IS NOT POSSIBLE. IF THE SAMPLE IS RETURNED AT A FUTURE DATE, THIS COMPLAINT MAY BE REOPENED FOR FURTHER EVALUATION AT THAT TIME. THERE WERE THREE SIMILAR COMPLAINTS REPORTED IN THE LOT.

    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.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY CORRECTED INFORMATION PROVIDED IN D.4.

    Description of Event or Problem · 0

    REPORTER INDICATED A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE CRACKED AND LEAKED FLUID. THIS ONE WAS IN JUST ABOUT 24 HOURS. PICC LINE: 26 GAUGE, LOT # 11488167 , CUT TO 30 CM, 3 CM OUT INSERTION DATE: (B)(6) 2024 @ 1530 , LEFT SAPHENOUS VEIN. THERE WAS NO PATIENT INJURY. IVF: NVN AND LIPIDS MEDS: AMPICILLIN, GENTAMICIN, FLAGYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1412037 L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM L-CATH PICC LJS ARGON MEDICAL DEVICES 384539 11488167 00886333209934

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown