MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 60CM; CATHETER, PERCUTANEOUS

Catalog Number JP-18763-C

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: this product is not sold in the us.The 510k # provided is for a similar product that is sold in the us.

Event Description

It was reported that the proximal port was found blocked because of blood withdrawal during use on a patient.Therefore, the catheter was replaced by a new one.

Manufacturer Narrative

(b)(4).The customer returned a single 3-lumen catheter for evaluation.Although the catheter appeared to have been cleaned, evidence of use was observed.Visual examination of the catheter body, catheter juncture hub and extension lines did not reveal any defects or anomalies.Evidence of use (dried blood) was observed in the proximal skive hole, on the proximal luer hub and on the catheter body.The catheter body length and outer diameter were measured and were found to be within specification.Each of the 3 extension lines were flushed with water to functionally test the catheter.Dried blood was observed exiting the catheter body when flushing the proximal extension line but all of the extension lines functioned as expected.A lab inventory 0.035" guide wire was able to pass through the distal extension line with minimal resistance.A device history record review was performed on the catheter and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit give specific instructions for maintaining cat heter patency.The ifu states "establish and maintain catheter patency by: flushing intermittently via syringe with heparinized saline or preservative-free 0.9% sodium chloride; continuous drip; positive pressure device note: neutral as well as positive displacement valve systems have also been shown to help prevent occlusion; properly cleanse all valves with an appropriate antiseptic before being accessed; the sash or sas method of flushing will help eliminate occlusions due to incompatible solutions: saline, administer drug, saline, heparin (if used)".The customer report of a blocked catheter could not be confirmed through testing of the returned sample.All three of the catheter extension lines were flushed with water and functioned as expected.The catheter met all other relevant functional, visual and dimensional testing.A device history record was performed on the catheter and no relevant manufacturing issues were identified.Based on the condition of the returned sample, no problem was found with this sample.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that the proximal port was found blocked because of blood withdrawal during use on a patient.Therefore, the catheter was replaced by a new one.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 60CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7361267
• MDR Text Key: 103279674
• Report Number: 3006425876-2018-00194
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• 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: 03/22/2018

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: 04/30/2022
• Device Catalogue Number: JP-18763-C
• Device Lot Number: 71F17E0134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 04/05/2018
• Supplement Dates FDA Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1