MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 2-L 16 GA X 19-1/2 IN (50 CM); CATHETER INTRAVASCULAR THERAPE

Catalog Number	PS-01652
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "an obstruction in the drum device was evidenced during the return verification, which prevented the advance of the saline solution.It was initially thought that the obstruction was from the patient;however, after a new verification, it was confirmed that the occlusion was located in a proximal area of the medical device connectors.A drum device was inserted.Once inserted, a return flow test was performed.This revealed a drum obstruction.Initially, it was thought to be the patient's.The return flow was verified again by sweeping with 0.9% ssn.An occlusion of the device was observed in an area close to the connectors, which prevented the device from progressing." 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) 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 no relevant findings were identified.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 "an obstruction in the drum device was evidenced during the return verification, which prevented the advance of the saline solution.It was initially thought that the obstruction was from the patient; however, after a new verification, it was confirmed that the occlusion was located in a proximal area of the medical device connectors.A drum device was inserted.Once inserted, a return flow test was performed.This revealed a drum obstruction.Initially, it was thought to be the patient's.The return flow was verified again by sweeping with 0.9% ssn.An occlusion of the device was observed in an area close to the connectors, which prevented the device from progressing." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW PICC SET: 2-L 16 GA X 19-1/2 IN (50 CM)
• 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: 22166497
• Report Number: 9680794-2025-00475
• Device Sequence Number: 13061443
• Product Code: LJS
• UDI-Device Identifier: 00801902095824
• UDI-Public: (01)00801902095824(11)241007(17)260331(10)14F24J0240(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: PS-01652
• Device Lot Number: 14F24J0240
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2024
• 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 Age: 67 YR
• Patient Sex: Female