MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AHDC AGB KIT: 2-L 14 FR X 20 CM; CATHETER, HEMODIALYSIS, TRIPLE

Catalog Number	CDC-25142-XCN1A
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn # (b)(4).
Event or Problem Description
The client complained that the plastic on the catheter is too ridged.They reported that this cause caused brachiocephalic injury, which had to be "fixed".Additional information was requested from the account.
Event or Problem Description
The client complained that the plastic on the catheter is too ridged.They reported tha this cause caused brachiocephalic injury, which had to "fixed".Additional information was requested from the account.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit states, "thread tip of catheter over guidewire.Grasping near skin, advance catheter into vein with slight twisting motion.Precaution: if resistance is encountered when attempting to remove guidewire after catheter placement, guidewire may be kinked around tip of catheter within vessel." the customer did not provide a lot number; therefore, 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 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.

• Brand Name: ARROW AHDC AGB KIT: 2-L 14 FR X 20 CM
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18720975
• Report Number: 9680794-2024-00201
• Device Sequence Number: 6235059
• Product Code: NIE
• UDI-Device Identifier: 10801902213553
• UDI-Public: 10801902213553
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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-25142-XCN1A
• Device Lot Number: UNKNOWN
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 03/14/2024
• 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