MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-15703-E
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The report states, "they found the defected introducer needle that cannot suck solution and cause air embolism into syringe when they insert the needle to the patient vessel.The problem solved by change the new cvc set".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer report of cracked needle hub was not able to be confirmed through analysis of the customer supplied photos and videos.The videos showed the introducer needle being functionally tested when attached to an ars and a non-arrow syringe.When drawing back on the syringe plungers, large amounts of air was observed entering the syringe barrels.Cracking on the needle hub can contribute to this observed defect; however, a complete visual analysis could not be performed on the needle to verify any damage.Neither the photos nor the videos explicitly show damage to the introducer needle.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 probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a; corrected data: n/a.
Event or Problem Description
The report states, "they found the defected introducer needle that cannot suck solution and cause air embolism into syringe when they insert the needle to the patient vessel.The problem solved by change the new cvc set".No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
The report states, "they found the defected introducer needle that cannot suck solution and cause air embolism into syringe when they insert the needle to the patient vessel.The problem solved by change the new cvc set".No patient harm or injury.The patient status is reported as "fine.".
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # **udi related data quality updates only**.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18402357
• Report Number: 3006425876-2023-01208
• Device Sequence Number: 4020658
• Product Code: DQY
• UDI-Device Identifier: 40801902127714
• UDI-Public: (01)40801902127714(11)220520(17)270430(10)71F22E1934(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2023

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 Catalogue Number: CS-15703-E
• Device Lot Number: 71F22E1934
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 01/18/2024; Not provided
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/19/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2022
• 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