MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 1-L 16 GA X 50 CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number ASK-01651-TRC

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 07/07/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported the extension line got torn during placement of the catheter.The catheter was removed and replaced with a new one.No patient harm reported.The patient's condition is reported as fine.

Event Description

It was reported the extension line got torn during placement of the catheter.The catheter was removed and replaced with a new one.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one s-l catheter for evaluation.Signs of use in the form of biological material and sutures were observed on the catheter body.Visual inspection confirmed the distal extension line was separated 13 mm from the luer hub.The separation point was rough and jagged.This is consistent with undue force being applied to the extension line.The extension line was separated 13 mm from the luer hub.The total length of the catheter measured 527 mm, which is within specifications of 500.1-550.9 mm per catheter graphic.The inner diameter of the distal extension line measured 0.058", which is within specifications of 0.055-0.059" per extrusion graphic.The outer diameter of the distal extension line measured 0.08490", which is within specifications of 0.084-0.088" per extrusion graphic.This indicates that the wall thickness is within specifications.The catheter was not able to be functionally tested due to the damage.A manual tug test confirmed the distal luer was secure to the extension line.A device history record review was performed, and no relevant findings were identified.The instructions for use provided with this kit warns the user, "do not apply excessive force in removing spring-wire guide or catheter.If withdrawal cannot be easily accomplished, a visual image should be obtained and further consultation requested.Do not use scissors to remove the dressing to minimize the risk of cutting the catheter.Do not suture directly to the outside diameter of the catheter to minimize the risk of cutting or damaging the catheter or impeding catheter flow.To minimize the risk of catheter breakage, do not exert excessive force while removing the catheter." the complaint of an extension line separated was confirmed by a complaint investigation on the returned sample.Visual inspection revealed the distal extension line was separated 13 mm from the luer hub.The separation point was rough and jagged, this is consistent with undue force being applied.A device history record review was performed, and no relevant findings were identified.Based on the sample returned and the customer description that the damage occurred during use, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ARROW CVC KIT: 1-L 16 GA X 50 CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 15115141
• MDR Text Key: 301346296
• Report Number: 3006425876-2022-00641
• Device Sequence Number: 1
• Product Code: LJS
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/27/2023
• Device Catalogue Number: ASK-01651-TRC
• Device Lot Number: 71F21D2871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2021
• 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