MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH SET: 20 GA X 1-3/4"; CATHETER PERCUTANEOUS

Model Number	IPN035913
Medical Device Problem Codes	Failure to Advance (2524); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint found in maude database reported as: "the doctor was placing a radial arterial line.He could not advance catheter and then the catheter split out of the side of it.".
Additional Manufacturer Narrative
(b)(4).The mdr report key/ report number is (b)(4).The mdr text key is (b)(4).
Additional Manufacturer Narrative
(b)(4).The mdr report key/ report number is 12778082.The mdr text key is 280536931.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 reported as: "the doctor was placing a radial arterial line.He could not advance catheter and then the catheter split out of the side of it.".

• Brand Name: ARROW RA CATH SET: 20 GA X 1-3/4"
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 13226839
• Report Number: 9680794-2022-00037
• Device Sequence Number: 17184738
• Product Code: DQY
• UDI-Device Identifier: 00801902027528
• UDI-Public: 00801902027528
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021120
• 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): 12/17/2021

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 Expiration Date: 05/31/2026
• Device Model Number: IPN035913
• Device Catalogue Number: RA-04020-SP
• Device Lot Number: 14F21E0113
• 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: 12/17/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• 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