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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " one extension lumen was out due to sharp edge of pinch clamp." the picc will be replaced on a future date.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "discharged".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4) the actual device was not returned; however, the customer provided one photo for analysis.The complaint of a separated extension line was confirmed by the photo.A complete visual inspection to determine the cause of the damage could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.The ifu provided with the kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." 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 " one extension lumen was out due to sharp edge of pinch clamp." the picc will be replaced on a future date.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "discharged".

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22468136
• Report Number: 9680794-2025-00602
• Device Sequence Number: 14521152
• Product Code: LJS
• UDI-Device Identifier: 00801902095787
• UDI-Public: (01)00801902095787(11)240925(17)260331(10)33F24H0239(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K112896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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-45552-HPHNM
• Device Lot Number: 33F24H0239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2024
• 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