MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L: 5FR X 50CM W/ 130CM SS SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35052-HPSL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "glide thru sheath broken halfway while removing".There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "glide thru sheath broken halfway while removing".There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine.".
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided one photo and one video for analysis.The complaint of peel-away sheath tears incorrectly was able to be confirmed by the photo and video.The photo and video show the extrusion portion of the peel-away sheath remaining on the catheter and the sheath tore incorrectly down the center.A device history record review was performed, and there were potential findings identified; however, it was determined the findings were not relevant.The instructions for use (ifu) provided with this kit warns the user, "precaution: avoid tearing sheath at insertion site which opens surrounding tissue creating a gap between catheter and dermis." the customer report of peel-away sheath tears incorrectly was confirmed by visual inspection of the customer supplied photo and video.It was determined the observed defect from the customer provided media is related to the tipping process.Based on these circumstances, manufacturing caused or contributed to the reported event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI PICC 2L: 5FR X 50CM W/ 130CM SS SWG
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21889348
• Report Number: 9680794-2025-00313
• Device Sequence Number: 3531092
• Product Code: LJS
• UDI-Device Identifier: 20801902095521
• UDI-Public: (01)20801902095521(11)230622(17)250531(10)14F23F0232(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: PR-35052-HPSL
• Device Lot Number: 14F23F0232
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown