ARGYLE
Received Jul 2, 2026 · Event occurred Jun 30, 2026
Report 1423537-2026-00215 · MDR key 25696241
Device
Generic name
Catheter,intravascular,therapeutic,short-term Less Than 30 Days
Manufacturer
Cardinal Health 200, LlcModel number
43304Catalog number
43304
Lot number
2430400160
Product problems
- Crack
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
THE CUSTOMER REPORTED THAT AT 17.40, THE SECONDARY LUMEN INFUSING TPN, LIPIDS, AND FENTANYL WAS NOTED BY THE REGISTERED NURSE (RN) TO BE CRACKED JUST ABOVE THE PURPLE BUTTERFLY BEFORE FIRST CAP. THE PICC NURSE AND CHARGE NURSE REMOVED THE LINE. MDS AND PARENTS WERE NOTIFIED. IT WAS UNKNOWN HOW LONG PICC HAD BEEN CRACKED, THROUGHOUT HOURLY CHECKS DURING SHIFT IT WAS OBSERVED THAT THE PICC WAS NOT VISIBLY LEAKING. THERE WAS NO HARM REPORTED.