MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CDC-45703-XPB1A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have had a reported leak with the white port on mml having a hole and leaking when flushing." the line was removed and replaced.The patient's current condition is reported as "deceased".It was reported "it is not felt that the device had any factor in the patient's death.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "we have had a reported leak with the white port on mml having a hole and leaking when flushing." the line was removed and replaced.The patient's current condition is reported as "deceased".It was reported "it is not felt that the device had any factor in the patient's death.".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of an extension line leak was able to be confirmed by the photos.Evidence of a hole was observed on the extension line towards the luer hub; however, a complete visual inspection to determine the nature and cause of the hole could not be performed as no sample was returned for analysis.Clinical and medical affairs (cma) was consulted and they stated, "the leak was localized, promptly addressed, and occurred in a lumen not used for guidewire passage.The defect was likely due to external damage [from a sharp instrument].Importantly, the patient's death occurred more than 12 hours after cvc removal, which rules out an acute event such as air embolism or device failure.Death is best explained by progression of pre-existing cardiogenic shock and comorbidities." 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 secure , staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the ifu also states, "when used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen.The maximum pressure of power injector equipment used with the pressure injectable cvc may not exceed 400psi.Warning: open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." the pressure injection info card states for a 7fr x 20cm, 3-lumen pi cvc, the max indicated pressure injection flow rate for the white proximal extension line is 5 ml/sec.All extension lines are intended to be used for pressure injection.The report of an extension line leak was confirmed through visual analysis of the customer photos.The customer provided photos show evidence of a hole on the body of the extension line towards the luer hub; however, a complete visual inspection to evaluate the cause of the damage could not be performed as no sample was returned for analysis.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 PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 23596107
• Report Number: 9680794-2025-00952
• Device Sequence Number: 13083949
• Product Code: FOZ
• UDI-Device Identifier: 20801902117223
• UDI-Public: (01)20801902117223(11)250325(17)260331(10)33F25B0504(21)
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2025

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: CDC-45703-XPB1A
• Device Lot Number: 33F25B0504
• 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: 10/25/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2025
• 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