MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 1L 4FRX55CM W/130CM HYDR NIT SWG; CATHETER INTRAVASCULAR THERAPE

Catalog Number	PR-35541-HPHNL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one peel-away sheath for analysis.No obvious signs of use were observed on the sheath.Visual inspection revealed that the peel-away sheath tore partway down the extrusion, causing the tab and extrusion to separate from the rest of the assembly.The sheath extrusion appeared partly stretched at the site of separation and the blue tear line.Microscopic examination confirmed the damage and revealed that the score lines on both sides of the sheath extrusion appeared wavy.It was also noted that one side of the score line was split completely down the extrusion.The sheath was severed to observe the cross section.The overall length of the sheath measured 4 1/16" which is within the specification limits of 3 7/8"-4 1/8" per the sheath product drawing.Functional inspection could not be accurately performed as a part of this complaint investigation due to the condition of the returned sample.Manufacturing was consulted as a part of this complaint investigation.They confirmed the defect is due to the extrusion process.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "precaution: avoid tearing sheath at insertion site which opens surrounding tissue creating a gap between catheter and dermis".The report that a peel-away did not tear correctly was confirmed through complaint investigation of the returned sample.Visual analysis revealed that one side of the extrusion tore partway, causing the tab and extrusion to separate from the assembly.Manufacturing was consulted as a part of this complaint investigation, and they confirmed that the likely cause of the defect is the extrusion process.Therefore , based on the customer report and the sample received, manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "when inserting the glidethru sheath during a picc insertion, one of the white handles on the sheath broke off." the user was able to remove the sheath and complete the procedure.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 "when inserting the glidethru sheath during a picc insertion, one of the white handles on the sheath broke off." the user was able to remove the sheath and complete the procedure.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW PI PICC 1L 4FRX55CM W/130CM HYDR NIT SWG
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 22495114
• Report Number: 9680794-2025-00611
• Device Sequence Number: 8094089
• Product Code: LJS
• UDI-Device Identifier: 00801902095565
• UDI-Public: (01)00801902095565(11)241106(17)260331(10)33F24K0699(21)
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: PR-35541-HPHNL
• Device Lot Number: 33F24K0699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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