MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 2-L 8 FR X 16 CM AGB; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CDC-42802-XP1A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: when they are dilating a vessel the tissue dilator tip is "shredding" and warps at the tip.There is no separation of the device and no harm to the patient.Another kit is opened to resolve.Associated complaints: 9680794-2024-00266 and 9680794-2024-00265.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn # (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
Event or Problem Description
It was reported that: when they are dilating a vessel the tissue dilator tip is "shredding" and warps at the tip.There is no separation of the device and no harm to the patient.Another kit is opened to resolve.Associated complaints: 9680794-2024-00266, 9680794-2024-00267 and 9680794-2024-00265.

• Brand Name: ARROW PI CVC KIT: 2-L 8 FR X 16 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18958654
• Report Number: 9680794-2024-00267
• Device Sequence Number: 17262942
• Product Code: FOZ
• UDI-Device Identifier: 10801902117110
• UDI-Public: 10801902117110
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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
• Device Catalogue Number: CDC-42802-XP1A
• Device Lot Number: UNKNOWN
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 04/30/2024
• 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