MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number IPN055195

Device Problem Obstruction of Flow (2423)

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

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported two of the extension lines were "dysfunctional".It was reported "the distal line was functional and there was visible blood flow.On the median and proximal lines, no flow; they seemed clogged.".The issue was detected immediately upon insertion.The catheter was replaced and there was a delay in treatment in the operating room.No patient harm reported.The patient's condition is reported as "stable".

Event Description

Customer reported two of the extension lines were "dysfunctional".It was reported "the distal line was functional and there was visible blood flow.On the median and proximal lines, no flow; they seemed clogged.".The issue was detected immediately upon insertion.The catheter was replaced and there was a delay in treatment in the operating room.No patient harm reported.The patient's condition is reported as "stable".

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer returned one representative cvc kit for evaluation.The kit was opened to further inspect its components.Visual inspection of the catheter revealed no obvious defects or anomalies.The total length of the catheter body measured to be 168 mm which is within the specification of 157-177 mm per product drawing.The outer diameter of the proximal lumen measured to be 2.14 mm which is within specifications of 2.13-2.21 mm per product drawing.The inner diameter of the proximal lumen measured to be 1.4478 mm which is within specifications of 1.42-1.50 mm per product drawing.This indicates that the wall thickness measured within specifications.The outer diameter of the medial lumen measured to be 2.16 mm which is within specifications of 2.13-2.21 mm per product drawing.The inner diameter of the medial lumen measured to be 1.4732 mm which is within specifications of 1.42-1.50 mm per product drawing.This indicates that the wall thickness measured within specifications.The outer diameter of the distal lumen measured to be 2.19 mm which is within specifications of 2.13-2.21 mm per product drawing.The inner diameter of the distal lumen measured to be 1.4478 mm which is within specifications of 1.42-1.50 mm per product drawing.This indicates that the wall thickness measured within specifications.The catheter was functionally tested per the instructions for use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." all lumens were flushed using a water-filled lab inventory syringe.All lumens flushed as expected.A manual tug test confirmed all extension lines were fully secured within the luer hubs.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.Do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations.Open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." the customer report of a blocked extension line could not be confirmed by complaint investigation of the returned sample.The customer returned one representative sample, and the returned catheter passed all relevant dimensional and functional inspection.A device history record review was performed with no relevant findings.The root cause for this complaint could not be determined as the actual device was not returned, and there was no problem found with the representative sample.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14084129
• MDR Text Key: 289081277
• Report Number: 3006425876-2022-00308
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• 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: 03/22/2022

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 Model Number: IPN055195
• Device Catalogue Number: CV-12703
• Device Lot Number: 71F21A0609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2021
• 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
• Treatment: NOT REPORTED.; NOT REPORTED.