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

Catalog Number	CDC-45703-XPCN1A
Medical Device Problem Codes	Crack (1135); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "per the charge nurse and the resident physicians they stated that the syringe that used to check for line placement by aspirating for blood in two separate kits were defective.The specific kits were the triple lumen cvc line, in one of the kits the syringe was visible cracked and when they attempted to aspirate blood, it leaked out of the crack and in the other kit the syringe did have not suction and would not aspirate and they were unable to check for placement."the physician was attempting to place a central line last night and yet again when attempting to check placement, the syringe provided in the kit did not have any suction and they could not aspirate any blood.They had to get another syringe and that syringe worked correctly." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2026-00212, 9680794-2026-00211, and 9680794-2026-00210.
Event or Problem Description
It was reported that "per the charge nurse and the resident physicians they stated that the syringe that used to check for line placement by aspirating for blood in two separate kits were defective.The specific kits were the triple lumen cvc line, in one of the kits the syringe was visible cracked and when they attempted to aspirate blood, it leaked out of the crack and in the other kit the syringe did have not suction and would not aspirate and they were unable to check for placement."the physician was attempting to place a central line last night and yet again when attempting to check placement, the syringe provided in the kit did not have any suction and they could not aspirate any blood.They had to get another syringe and that syringe worked correctly." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2026-00212, 9680794-2026-00211, and 9680794-2026-00210.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and there was one potential finding.Without the sample returned, it cannot be confirmed if the failure mode of this event is the same as/relevant to the finding identified.The instructions for use (ifu) provided with this kit warns the user, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate." without the device to evaluate the complaint could not be confirmed and 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.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• 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: 24626738
• Report Number: 9680794-2026-00212
• Device Sequence Number: 21004743
• Product Code: FOZ
• UDI-Device Identifier: 10801902161243
• UDI-Public: (01)10801902161243(11)250910(17)270331(10)33F25J0290(21)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/03/2026

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 Catalogue Number: CDC-45703-XPCN1A
• Device Lot Number: 33F25J0290
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2025
• 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