MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH KIT: 20 GA X 1-3/4IN; WIRE GUIDE CATHETER

Catalog Number	NA-04020-S1A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that:"product defective".The issue was identified during use on patient.The product leaked blood.Pt was in critical condition.It was discovered quickly; arterial line went flat on central monitoring.We had to discontinue existing line and replace.There was no medical intervention other than replacing.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).Udi# (b)(4).The customer report of a leaking stopcock was confirmed through investigation of the returned sample.The customer returned one tubing assembly as part of an arterial kit for analysis.Definite evidence of use was observed on the tubing.Visual and functional testing revealed a crack in the stopcock as a part of the tubing assembly.The appearance of the crack is consistent with over tightening of the hub.A device history record review was performed with no relevant findings.Therefore, based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that:"product defective".The issue was identified during use on patient.The product leaked blood.Pt was in critical condition.It was discovered quickly; arterial line went flat on central monitoring.We had to discontinue existing line and replace.There was no medical intervention other than replacing.

• Brand Name: ARROW RA CATH KIT: 20 GA X 1-3/4IN
• Common Device Name: WIRE GUIDE CATHETER
• 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, NC 27560
• MDR Report Key: 19758910
• Report Number: 9680794-2024-00702
• Device Sequence Number: 17786830
• Product Code: DQX
• UDI-Device Identifier: 10801902139396
• UDI-Public: (01)10801902139396(11)231219(17)250331(10)33F23L0731(21)
• Combination Product (Y/N): N
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: 03/31/2025
• Device Catalogue Number: NA-04020-S1A
• Device Lot Number: 33F23L0731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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