MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN036855
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The mdr report key/report number is (b)(4).The mdr text key is (b)(4).
Event or Problem Description
Complaint found in maude database reports: "the advanced practice provider (app) was placing a line for continuous renal replacement therapy (crrt).Ultrasound was used to find vessel, the guide wire was placed, needle removed, small incision made, and line was placed.While removing the guide wire it became what felt like "stuck".Upon removal the "hooked" part of the guide wire was frayed.".
Additional Manufacturer Narrative
Qn(b)(4).The mdr report key/report number is (b)(4).The mdr text key is (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
Event or Problem Description
Complaint found in maude database reports: "the advanced practice provider (app) was placing a line for continuous renal replacement therapy (crrt).Ultrasound was used to find vessel, the guide wire was placed, needle removed, small incision made, and line was placed.While removing the guide wire it became what felt like "stuck".Upon removal the "hooked" part of the guide wire was frayed.".

• Brand Name: ARROW CVC KIT: 3-LUMEN 12 FR X 20 CM
• 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: 14312630
• Report Number: 9680794-2022-00273
• Device Sequence Number: 17399994
• Product Code: FOZ
• UDI-Device Identifier: 60801902122089
• UDI-Public: 60801902122089
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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: 07/31/2023
• Device Model Number: IPN036855
• Device Catalogue Number: AK-15123-F
• Device Lot Number: 13F21J0523
• 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: 04/13/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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
• Patient Sex: Unknown