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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter leaked when flushed.The catheter had been inserted since 22 may.The catheter was removed and a new catheter was placed.It was reported the patient "is currently in good condition with no adverse reactions".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one video and one photo for analysis.The complaint of leaking extension line was confirmed.A leak is visible towards the distal luer hub; however, the exact location and appearance of the leak cannot be verified without the actual sample returned for analysis.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.No relevant findings were identified.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 and video.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based on a potential lot from sales history, 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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that the catheter leaked when flushed.The catheter had been inserted since (b)(6).The catheter was removed and a new catheter was placed.It was reported the patient "is currently in good condition with no adverse reactions".

• 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: 17905694
• Report Number: 9680794-2023-00740
• Device Sequence Number: 20718570
• 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: 11/01/2023
• 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