inforMED
MalfunctionFOZ

ARGYLE

Received Jun 30, 2026 · Event occurred Jun 11, 2026

Report 1423537-2026-00211 · MDR key 25664677

Device

Generic name

Catheter,intravascular,therapeutic,short-term Less Than 30 Days

Model number

43304

Catalog number

43304

Lot number

2511900062

Product problems

  • Leak/Splash

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

ADDITIONAL PRODUCT CODE D2A: LJS. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE PICC SECOND LUMEN WAS LEAKING FROM TINY HOLE OR CRACK IN LUMEN CLOSE TO PATIENT. MD AND CHARGE NURSE WERE NOTIFIED AND A NEW PICC LINE HAD TO BE INSERTED. THE FAULTY PICC WAS REMOVED, AND BLOOD CULTURE WAS DRAWN TO MONITOR FOR INFECTION RELATED TO BREAK IN CENTRAL LINE. ACCORDING TO THE CUSTOMER, THE INFANT WILL REQUIRE FURTHER MONITORING.