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	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "the peripherally inserted central venous catheter (picc) was removed from the patient per the treating physician's order.Upon removal, the catheter was observed to be fractured at its distal and mid segments." 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).The actual device was not returned; however, the customer provided one video for analysis.The video shows a used catheter with evidence of ruptures at three locations in the catheter body.The portions of the body at the points of rupture are kinked and distorted, however, a complete visual inspection to determine the cause of the damage could not be performed as no sample was returned for analysis.Additional information from the customer suggests that the catheter was functional within the patient for ten (10) days prior to the reported rupture.In addition, they confirmed the catheter was not used as a contrast medium.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "ensure catheter patency prior to use, including prior to pressure injection.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture." the contraindication label on the product lidstock states, "contraindications: the picc is contraindicated wherever there is presence of device related infections or presence of thrombosis in the intended insertion vessel or catheter pathway.Clinical assessment of the patient must be completed to ensure no contraindications exist." the customer report of catheter rupture was confirmed by visual inspection of the customer supplied video.The video shows a used catheter with evidence of with ruptures at three locations in the catheter body.The portions of the body at the points of rupture are kinked and distorted, however, full complaint verification testing 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.Without the device to evaluate, 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 peripherally inserted central venous catheter (picc) was removed from the patient per the treating physician's order.Upon removal, the catheter was observed to be fractured at its distal and mid segments." 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: 23133086
• Report Number: 9680794-2025-00792
• Device Sequence Number: 8842844
• Product Code: LJS
• UDI-Device Identifier: 00801902095824
• UDI-Public: (01)00801902095824(11)241202(17)260331(10)14F24K0091(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): 08/29/2025

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: 14F24K0091
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2024
• 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