MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM PICC 2L 5.5FRX55CM 80CM HYDRO NIT SWG; CATHETER INTRAVASCULAR THERAPE

Catalog Number	PR-45552-HPHNM
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the doctor has been having issues with the peel away sheath in the ir picc kits.He can crack it fine but its not "peeling" away, its more like shredding.He has to pull the picc out and try to use a hemostat to try to grab the sheath and pull it out that way.This same issue has happened 4-5 times now.Associated complaints: 9680794-2024-00269, 9680794-2024-00270, 9680794-2024-00271, and 9680794-2024-00272.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and relevant findings were identified.For part number eb-01052-002 with batch 34c23f0167, a non-conformance was created for the issue of peel-away sheath tears incorrectly; however, without the sample returned for analysis, it cannot be determined if the finding is relevant to the reported event.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: the doctor has been having issues with the peel away sheath in the ir picc kits.He can crack it fine but its not "peeling" away, its more like shredding.He has to pull the picc out and try to use a hemostat to try to grab the sheath and pull it out that way.This same issue has happened 4-5 times now.Associated complaints: 9680794-2024-00269, 9680794-2024-00270, 9680794-2024-00271, 9680794-2024-00272 and 9680794-2024-00273.

• Brand Name: ARROW AM PICC 2L 5.5FRX55CM 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18960340
• Report Number: 9680794-2024-00273
• Device Sequence Number: 20846120
• Product Code: LJS
• UDI-Device Identifier: 00801902095787
• UDI-Public: 00801902095787
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K112896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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: 06/30/2025
• Device Catalogue Number: PR-45552-HPHNM
• Device Lot Number: 33F23H0482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2023
• 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