MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L 5FRX55CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35552-HPHNM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "radiologist inserted picc in right upper arm basilic vein under imaging with no problems.The peel-away sheath tabs were grasped and the sheath pulled apart 1cm.At the 1cm point the tab and the 1cm of sheath tore off completely on one side, leaving the other tab intact.So one tab and 1cm of sheath tore off.The inserter had to use a scalpel to make small "nicks" into remaining part of sheath to remove and peel away the peel-away sheath.The sheath was successfully removed and did not appear to be punctured and remained in the patient.The concern was that the scalpel may puncture the picc but it was felt this was the only way to safely remove the sheath without part of the peel-away sheath tearing or slipping off and going into the vessel." there was no reported patient harm or consequence.
Additional Manufacturer Narrative
Qn# (b)(4).The customer report of peel-away sheath tabs breaking off in use was not confirmed through investigation of the returned sample.The returned sample was an unopened, representative sample, and the reported sample was not returned.The representative peel-away sheath met all relevant dimensional and functional requirements and peeled as expected during lab testing.A device history record review was performed, and no relevant findings were identified.Based on the customer report and without the reported sample returned, the root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "radiologist inserted picc in right upper arm basilic vein under imaging with no problems.The peel-away sheath tabs were grasped and the sheath pulled apart 1cm.At the 1cm point the tab and the 1cm of sheath tore off completely on one side, leaving the other tab intact.So one tab and 1cm of sheath tore off.The inserter had to use a scalpel to make small "nicks" into remaining part of sheath to remove and peel away the peel-away sheath.The sheath was successfully removed and did not appear to be punctured and remained in the patient.The concern was that the scalpel may puncture the picc but it was felt this was the only way to safely remove the sheath without part of the peel-away sheath tearing or slipping off and going into the vessel." there was no reported patient harm or consequence.

• Brand Name: ARROW PI PICC 2L 5FRX55CM W/80CM HYDRO NIT 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19058110
• Report Number: 9680794-2024-00312
• Device Sequence Number: 6030199
• Product Code: LJS
• UDI-Device Identifier: 00801902095619
• UDI-Public: 00801902095619
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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: 04/30/2025
• Device Catalogue Number: PR-35552-HPHNM
• Device Lot Number: 33F23E0497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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