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

Catalog Number	PS-01652
Medical Device Problem Codes	Material Puncture/Hole (1504); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the catheter was noted to have deformities and bends on it.The issue was identified prior to inserting into patient.There was no patient harm or consequence.
Event or Problem Description
It was reported that: the catheter was noted to have deformities and bends on it.The issue was identified prior to inserting into patient.There was no patient harm or consequence.
Additional Manufacturer Narrative
(b)(4), the actual device was not returned; however, the customer provided one video for analysis.The complaint of a kinked catheter was able to be confirmed by the video.The video shows a picc in the clinical setting with a compression/kink in the middle of the body, however, a complete visual inspection 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 instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." 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.

• Brand Name: ARROW PICC SET: 2-L 16 GA X 19-1/2" (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: 18149084
• Report Number: 9680794-2023-00888
• Device Sequence Number: 17582567
• Product Code: LJS
• UDI-Device Identifier: 00801902095824
• UDI-Public: 00801902095824
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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: 12/31/2024
• Device Catalogue Number: PS-01652
• Device Lot Number: 14F23A0069
• 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: 10/19/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• 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