MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L 5FRX40CM W/80CM HYDRO NIT SWG; CATHETER INTRAVASCULAR THERAPE

Catalog Number	PR-34052-HPHNM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the transparent catheter of the picc pink connector was broken".The catheter was removed.The patient's condition is "fine".
Event or Problem Description
It was reported "the transparent catheter of the picc pink connector was broken".The catheter was removed.The patient's condition is "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of an extension line leaks was able to be confirmed by the photo.A hole had formed on the distal extension line directly adjacent to the pink luer hub.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.One relevant finding was identified.A non-conformance was opened to address the issue.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The customer report of a leaking extension line was confirmed by visual inspection of the customer supplied photo.Visual analysis of the photo revealed that a hole had formed on the distal extension line directly adjacent to the luer hub.Based on visual analysis of the customer photo and confirmation from the customer, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI PICC 2L 5FRX40CM W/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: 17905993
• Report Number: 9680794-2023-00738
• Device Sequence Number: 7467984
• Product Code: FOZ
• UDI-Device Identifier: 00801902100979
• UDI-Public: 00801902100979
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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
• Device Catalogue Number: PR-34052-HPHNM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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