MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L 5FRX50CM W/80CM HYDRO NIT SWG; CATHETER INTRAVASCULAR THERAPE

Catalog Number	PR-35052-HPHNM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "when the radiologist attempted to peel the peel-away sheath, the plastic material tore, leaving a portion of it inside the patient.The radiologist was able to retrieve the remaining piece using forceps immediately".After the sheath was removed with forceps, the picc line was placed successfully.The patient had no harm or health consequences from this incident.
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided one photo for analysis.The customer report of a sheath tearing incorrectly was able to be confirmed as the photo displayed the sheath extrusion torn partway down the body.The customer returned one sheath for analysis.Definite signs of use were observed on the returned sample.Visual and microscopic analysis revealed that the peel away sheath completely torn down both score lines with both extrusions were still molded to the sheath tabs.One side of the extrusion was torn partway down the body.The appearance of the sheath tear along the score lines was additionally scalloped, which is not the intended appearance of the sheath once torn.The overall length of the sheath measured 4" which is within the specification limits of 3 7/8 - 4 1/8" per the sheath product drawing.The sheath outer and inner diameters could not be measured due to the condition of the returned sample.Functional inspection could not be performed due to the condition of the returned sample.A device history record review was performed and multiple relevant findings were identified.Several non-conformances were created for part number eb-01051-002 with batch 34c23k0159 and batch 34c23k0253.The non-conformances were opened for the peel-away sheath tears incorrectly failure.The ifu provided with this kit informs the user, "precaution: avoid tearing sheath at insertion site which opens surrounding tissue creating a gap between catheter and dermis.".The customer report of a peel away sheath tearing incorrectly was confirmed through investigation of the returned sample.Visual examination of the customer photo and returned sample displayed the sheath extrusion torn partway down the body.The appearance of the score lines was additionally scalloped, which is not the intended appearance of the sheath once torn.Therefore, based on the customer report and photo , manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that "when the radiologist attempted to peel the peel-away sheath, the plastic material tore, leaving a portion of it inside the patient.The radiologist was able to retrieve the remaining piece using forceps immediately".After the sheath was removed with forceps, the picc line was placed successfully.The patient had no harm or health consequences from this incident.The associated emdr report numbers are 9680794-2025-00009 and 9680794-2025-00099.

• Brand Name: ARROW PI PICC 2L 5FRX50CM W/80CM HYDRO 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: 21067499
• Report Number: 9680794-2025-00009
• Device Sequence Number: 20932449
• Product Code: LJS
• UDI-Device Identifier: 00801902101099
• UDI-Public: (01)00801902101099(11)231116(17)250831(10)33F23H0142(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 08/31/2025
• Device Catalogue Number: PR-35052-HPHNM
• Device Lot Number: 33F23H0142
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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