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

Catalog Number JP-18763-C

Device Problems Partial Blockage (1065); Inability to Irrigate (1337)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device product is not sold in the us.Similar product is sold in the us.

Event Description

The customer reports the distal lumen of the catheter was blocked and unable to flush.A new kit was used without issue.

Manufacturer Narrative

Qn# (b)(4).The customer returned a 3-lumen cvc catheter and the product lidstock for evaluation.Dried blood was observed on the catheter body.Visual examination of the catheter did not reveal any defects or anomalies.Dried blood was observed in each of the three of the extension line bodies.Dried blood was also observed in both of the skive holes in the distal end of the catheter.The catheter body length and outer diameter were measured and were found to be within specification.To functionally test the catheter for blockages the 3 extension lines were flushed with water using a 10ml lab inventory syringe filled with water.During initial flushing, the distal and proximal extension lines flushed as expected but the medial extension line was blocked.The medial extension line was able to be unblocked by placing significant force to the syringe plunger and by running a solid 0.012" core wire through the lumen.Blood was observed exiting the medial skive hole as the blockage was cleared.Once the medial extension line was cleared of dried blood, it functioned as expected when flushed with water.Therefore, the blockages observed by the customer are likely a result of dried blood within the medial catheter lumen.Other remarks: a lab inventory 0.035" guide wire was passed through the catheter via the distal tip.The guide wire was able to pass through the catheter body and out the distal extension line with minimal resistance.A device history record review on the catheter and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit provides detailed instructions on maintaining catheter 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.Neutral as well as positive displacement valve systems have also been shown to help prevent occlusion." the customer report of a blocked catheter extension line was confirmed through functional testing of the returned sample.The medial extension line was found to be partially blocked during initial flush testing of the three catheter lumens.The medial extension line was able to be cleared of dried blood by placing significant force on a syringe filled with water and clearing the line with a solid core wire.After the medial line was cleared of dried blood the catheter functioned as expected when flushed with water; therefore, the blockage observed by the customer is likely a result of the dried blood.The catheter met all relevant dimensional requirements and a device history record review did not reveal any manufacturing related issues.Based on the condition of the returned sample and the report that the damage was observed during use, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports the distal lumen of the catheter was blocked and unable to flush.A new kit was used without issue.

• 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: 7533269
• MDR Text Key: 108898975
• Report Number: 3006425876-2018-00306
• 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: 05/09/2018

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: 01/31/2019
• Device Catalogue Number: JP-18763-C
• Device Lot Number: 71F17B2080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1