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

Catalog Number CS-15703-E

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported " the doctor found the swg kinked during used on the patient." they changed to a new set.No patient harm or injury.No medical intervention required.The patient's current condition is rported as "fine".

Event Description

It was reported " the doctor found the swg kinked during used on the patient." they changed to a new set.No patient harm or injury.No medical intervention required.The patient's current condition is rported as "fine".

Manufacturer Narrative

(b)(4) the customer returned an opened cvc kit including one guide wire within its advancer, an arrow raulerson syringe (ars), and 18ga introducer needle for evaluation.The guide wire was returned within the advancer tube and no obvious signs of use were observed on the guide wire.The guide wire was observed to have no kinks on the body.The distal j-bend was not misshapen and was intact.Both welds were present and were observed to be full and spherical.No other defects or anomalies were observed on the returned components.The overall length of the guide wire measured 456 mm, which is not within the specification limits of 596-604 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.786 mm, which is not within the specification limits of 0.788-0.826 mm per guide wire product drawing.The customer was contacted regarding the dimensional discrepancies, and they were confirmed to have reported the incorrect material and batch number.The guide wire was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was advanced through the returned ars and 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components with little to no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution , "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.".The report of a kinked guide wire was not confirmed through examination of the returned sample.No defects are anomalies were observed on the returned guide wire.Additionally, the returned guide wire did not match dimensional specifications of the guide wire provided in the reported finished good as the customer reported the incorrect finished good and batch number.A device history record review did not identify any manufacturing related issues.Based on these circumstances and the customer description, the root cause could not be determined due to the discrepancy between the reported device and the returned sample.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19190644
• MDR Text Key: 341357212
• Report Number: 3006425876-2024-00392
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 40801902127714
• UDI-Public: 40801902127714
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-15703-E
• Device Lot Number: 71F20A2402
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED