MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 3-LUMEN 7FR X 30CM; CATHETER, PERCUTANEOUS

Catalog Number ASK-14703-KR

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the catheter was found kinked at about 22cm from the tip during the procedure.Therefore, the catheter was replaced with a new one.No injury to the patient was reported." no medical intevention required.The patient's current conditon is reported as "fine".

Manufacturer Narrative

Qn # (b)(4).The customer returned one, 2-lumen catheter and product lidstock for analysis.The product tray was not returned.No obvious signs of use were observed.Visual analysis revealed that the catheter contained two kinks along the catheter body extrusion towards the juncture hub.No other defects or anomalies were observed on the catheter.The kinks measured approximately 70 mm and 93 mm from the juncture hub.The overall length of the catheter body measured 320 mm, which is within the specification limits of 307-327 mm per the catheter product drawing.The outer diameter of the catheter body measured 2.40 mm, which is within the specification limits of 2.39-2.49 mm per the catheter extrusion drawing.The catheter was functionally tested per the instructions-for-use (ifu) provided with this kit which instructs the user, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire." a lab inventory 0.0826 mm guide wire was advanced through the catheter and minor resistance was experienced at the kinked locations.The undamaged portions of the guide wire passed with little to no resistance.Packaging r & d and the packaging facility were contacted as a part of this complaint investigation.Packaging r & d stated that the root cause cannot be confirmed (component interaction within the kit, misplaced catheter, excessive shipping/storage or other) without the packaging returned.The packaging facility stated that the components are visually inspected when placed into the tray.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." the customer report of a kinked catheter was confirmed through investigation of the returned sample.The catheter contained two kinks along the body extrusion towards the juncture hub.Despite this, the catheter passed all relevant dimensional and functional requirements.Packaging r & d and the packaging facility were contacted, and they stated that without the packaging returned, it cannot be confirmed when the damage occurred.Additionally, components are visually inspected during the kit packaging process.A device history record review revealed no relevant findings.Based on the customer report, sample received, and comments from packaging r & d and the packaging facility, the potential root cause cannot be determined at this time.Teleflex will continue to monitor and trend on reports of this nature.

Event Description

It was reported "the catheter was found kinked at about 22cm from the tip during the procedure.Therefore, the catheter was replaced with a new one.No injury to the patient was reported." no medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC KIT: 3-LUMEN 7FR X 30CM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19058809
• MDR Text Key: 339792610
• Report Number: 3006425876-2024-00332
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 03/14/2024

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
• Device Catalogue Number: ASK-14703-KR
• Device Lot Number: 71F22H1763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• 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