MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number ASK-15703-KR

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, the catheter was placed to the patient in april 28 about 22:00.In april 29 about 3:00, it was found migrated from the patient's body spontaneously.A 2-lumen catheter was placed for patient to continue treatment.No patient harm reported.

Event Description

It was reported that, the catheter was placed to the patient in april 28 about 22:00.In april 29 about 3:00, it was found migrated from the patient's body spontaneously.A 2-lumen catheter was placed for patient to continue treatment.No patient harm reported.

Manufacturer Narrative

(b)(4).The customer returned one 3-l cvc catheter for evaluation.Visual inspection of the catheter did not reveal and defects or anomalies.Both suture wings were intact.The length of the catheter body measured 220 mm, which is within specifications of 207-227 mm per catheter product drawing.The outer diameter of the catheter body measured 2.452 mm, which is within specifications of 2.39-2.49 mm per catheter extrusion.All three lumens were flushed to functionally test per the instructions for use (ifu).The ifu states, "flush each lumen with sterile saline solution, to establish patency and prime lumen(s)." all three lumens were found to be blocked with biological material.The biological material was cleared with a wire.All three lumens were then able to be flushed as expected.A manual tug confirmed all hubs were secure to their extension lines.The box clamp assembly was tugged but it was found to be secure to the catheter body.A device history record review was performed with no manufacturing issues identified.The instructions for use (ifu) provided with this kit instructs the user, "secure catheter: use a catheter clamp, fastener, catheter stabilization device, staples or suture, where provided.Use triangular juncture hub with side wings as primary suture site.Use catheter clamp and fastener as a secondary suture site as necessary." the complaint of a catheter migrating could not be confirmed through complaint investigation of the returned sample.The catheter passed all dimensional and functional testing.A device history record review was performed with no manufacturing issues identified.Based on the catheter returned, no problem was found on the returned catheter.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11853068
• MDR Text Key: 251722696
• Report Number: 3006425876-2021-00448
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

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 Operator: No Information
• Device Expiration Date: 08/02/2022
• Device Catalogue Number: ASK-15703-KR
• Device Lot Number: 71F20H0803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.