MalfunctionPWR
ARROW PI PICC 2L 5FRX40CM W/80CM HYDRO NIT SWG
Received Jul 3, 2026 · Event occurred Jun 5, 2026
Report 9680794-2026-00492 · MDR key 25704992
Device
Generic name
Catheter, Intravascular, Ther
Manufacturer
Arrow International LlcCatalog number
PR-34052-HPHNM
Lot number
33F26B0310
Product problems
- Material Separation
Patient
Unknown
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PEEL-AWAY SHEATH DID NOT SEPARATE ALONG THE INTENDED CENTER TEAR LINE. IN AN ATTEMPT TO PEEL THE SHEATH APART, ADDITIONAL FORCE WAS APPLIED, RESULTING IN STRETCHING AND DEFORMATION OF THE SHEATH. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RESPONDED TO REQUESTS FOR ADDITIONAL INFORMATION. THEREFORE, NO FURTHER DETAILS ARE AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY.
Additional Manufacturer Narrative
(B)(4).