MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW 2-L CVC KIT: 4 FR X 8 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CDC-25402-X1A
Medical Device Problem Codes	Material Twisted/Bent (2981); Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "while placing the actual cvc line (after initial placement of guidewire, skin nick, dialator insertion, confirming guidewire free and mobile, etc.) the guidewire kinked and migrated out of rij vessel.This necessitated new attempt for placement of line (using a different guidewire from a cook catheter kit).Additional information from the customer was requested, no information is available at this time.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, 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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Corrected data: section d.4.Partial udi number removed.The full udi number is not available as complainant did not report a lot number.
Event or Problem Description
It was reported "while placing the actual cvc line (after initial placement of guidewire, skin nick, dialator insertion, confirming guidewire free and mobile, etc.) the guidewire kinked and migrated out of rij vessel.This necessitated new attempt for placement of line (using a different guidewire from a cook catheter kit).Additional information from the customer was requested, no information is available at this time.

• Brand Name: ARROW 2-L CVC KIT: 4 FR X 8 CM
• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19444821
• Report Number: 9680794-2024-00511
• Device Sequence Number: 3214096
• Product Code: FOZ
• UDI-Device Identifier: 20801902116974
• UDI-Public: 20801902116974
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K900263
• 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,Followup
• Report Date (Section B): 05/06/2024

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-25402-X1A
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/02/2024
• Supplement Report FDA Received Date: 07/02/2024
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown