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	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one dilator.Obvious signs of use were observed.The customer reported that "dilator looks frayed at the end after being removed from the patient.Doctor reported that this has happened at least four times in the last two weeks." visual analysis of the dilator revealed a widening at the distal tip.Microscopic examination revealed the damage at the dilator tip.The appearance of the widening is consistent with damage due to improper insertion techniques.The dilator length measured 3 7/8", which is within the specification limits of 3 3/4" - 4 1/4" per the dilator product drawing.The dilator outer diameter measured 0.119", which is within the specification limits of 0.117" - 0.120" per the dilator extrusion product drawing.The dilator inner diameter at the distal tip measured 0.036", which is within the specification limits of 0.036" - 0.038" per the dilator extrusion product drawing.A lab inventory 0.826mm guidewire was inserted through the dilator tip.The guidewire was able to pass with little to no difficulty.Performed per ifu statement, "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin." a device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of a damaged dilator tip was confirmed through complaint investigation.Visual analysis revealed that the dilator tip was misshapen.Despite the damage, all relevant dimensional and functional requirements were met, and a device history record review did not reveal any relevant findings.Based on the customer report that the defect occurred during use and the appearance of the damage, the root cause cannot be determined as it cannot be determined when the damage occurred.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that the dilator "looks frayed at the end" after being removed from the patient.The doctor reported that this has happened at least four times in the last two weeks.The patient is fine and had no harm or injury.The associated emdr report numbers are 9680794-2025-00038, 9680794-2025-00037 and 9680794-2025-00036.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 21112339
• Report Number: 9680794-2025-00039
• Device Sequence Number: 21012355
• Product Code: FOZ
• UDI-Device Identifier: 10801902117110
• UDI-Public: (01)10801902117110(11)240917(17)251130(10)33F24H0389(21)
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2024

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 Expiration Date: 11/30/2025
• Device Catalogue Number: CDC-42802-XP1A
• Device Lot Number: 33F24H0389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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.
• Patient Sex: Unknown