BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC¿ S/L PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 16768837 · Received April 19, 2023

    Report

    Report Number
    0001625425-2023-01030
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    March 24, 2023
    Report Date
    May 30, 2023
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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

    A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO SIMILAR CONCERNS WERE FOUND. ONE OPENED CATHETER WAS RETURNED FOR REVIEW. VISUAL INSPECTION OF THE SAMPLE CONFIRMED THE SILICONE EXTENSION WAS DETACHED FROM THE CATHETER TUBING JUST BELOW THE INVERTED TRIANGLE BENEATH THE SECUREMENT DISC. THE BREAKAGE SITE EXHIBITED JAGGED EDGES WHICH IS INDICATIVE OF A TENSILE FORCE APPLIED TO THE CATHETER. A DEFINITE ROOT CAUSE FOR THE BREAKAGE IS NOT CERTAIN. DUE TO THE JAGGED EDGES, POSSIBLY AN EXCESSIVE FORCE WAS APPLIED TO THE CATHETER. SINCE THE REPORTED ISSUE WAS MOST LIKELY THE RESULT OF AN EVENT WITHIN THE USER ENVIRONMENT, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. ARGON WILL CONTINUE TO MONITOR FOR ISSUES OF THIS NATURE IN THE FUTURE.

    Description of Event or Problem · 0

    DESCRIBE THE EVENT OR PROBLEM: PATIENT MOVED ARM UP AND ARGON NEONATAL PICC LINE SNAPPED IN HALF CAUSING PATIENT TO LOSE CENTRAL ACCESS. NEONATAL PICC WAS SECURED PER NEONATAL INTENSIVE CARE UNIT POLICY, EXTENSION TUBING BEYOND DRESSING IS WHERE THE LINE SNAPPED IN HALF. PATIENT HAD TOTAL PARENTERAL NUTRITION (TPN), LIPIDS, AND PROSTAGLANDINS (PGE) RUNNING THROUGH LINE. NEONATAL PICC PULLED FROM PATIENT'S ARM, LINE INTACT AND SAVED IN BIOHAZARD BAG. PATIENT GOING FOR OPEN HEART IN OR THIS MORNING. PATIENT ON PEDIALYTE FOR FEEDS AFTER MIDNIGHT AND NOTHING BY MOUTH (NPO). PATIENT REQUIRED IV 10% DEXTROSE SOLUTION (D10) TO REPLACE TPN, AND NOW REQUIRING Q3 GLUCOSE CHECKS.

    Description of Event or Problem · 0

    DESCRIBE THE EVENT OR PROBLEM: PATIENT MOVED ARM UP AND ARGON NEONATAL PICC LINE SNAPPED IN HALF CAUSING PATIENT TO LOSE CENTRAL ACCESS. NEONATAL PICC WAS SECURED PER NEONATAL INTENSIVE CARE UNIT POLICY, EXTENSION TUBING BEYOND DRESSING IS WHERE THE LINE SNAPPED IN HALF. PATIENT HAD TOTAL PARENTERAL NUTRITION (TPN), LIPIDS, AND PROSTAGLANDINS (PGE) RUNNING THROUGH LINE. NEONATAL PICC PULLED FROM PATIENT'S ARM, LINE INTACT AND SAVED IN BIOHAZARD BAG. PATIENT GOING FOR OPEN HEART IN OR THIS MORNING. PATIENT ON PEDIALYTE FOR FEEDS AFTER MIDNIGHT AND NOTHING BY MOUTH (NPO). PATIENT REQUIRED IV 10% DEXTROSE SOLUTION (D10) TO REPLACE TPN, AND NOW REQUIRING Q3 GLUCOSE CHECKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937216 FIRST PICC¿ S/L PERIPHERALLY INSERTED CENTRAL CATHETER FIRST PICC FOZ ARGON MEDICAL DEVICES UNK 11452818

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R