MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH BASIC 22GAX6CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number EDC-00622-B

Device Problems Fluid/Blood Leak (1250); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Complaint description: after insertion when the needle and guidewire were removed, the port the needle and guidewire come out of did not seal.When flushed, fluid leaded out and when aspirated air was being sucked in.Used a different lot number without any issues.

Event Description

Complaint description: after insertion when the needle and guidewire were removed, the port the needle and guidewire come out of did not seal.When flushed, fluid leaded out and when aspirated air was being sucked in.Used a different lot number without any issues.

Manufacturer Narrative

Qn#(b)(4).The customer returned one endurance device for evaluation.Visual inspection of the catheter valve revealed a small hole near the center of the white proximal valve.Though the catheter did not fail functional testing the blue cap was broken open to inspect the valves inside.The hole was observed to be continuous through both the proximal and distal valves with no signs of the slits, meaning a leak could have occurred before.Also bio material was observed inside the hole in the valves that could have blocked the device from leaking again.The hole appears rough and jagged.The sample was attached to a 5ml syringe at the side extension hub and water was flushed through the catheter and out the distal end.The catheter functioned as expected with no leaks observed.The sample was then clamped at the distal end of the catheter and flushed again with the 5ml syringe.No leaks were observed.The catheter was then hooked up to the leak tester and tested at 300kpa for 30secs.Again, no leaking was observed.A dhr review was completed with no relevant findings.The customer complaint of the catheter leaking was not confirmed through this investigation.The returned device was not found leaking during functional testing.However, a hole was observed during visual inspection throughout both internal valves.The hole was similar to other holes observed in two other complaints that were found to be leaking.A dhr review was completed with no relevant findings.Based on the sample received, the root cause of this investigation is deemed manufacturing related.A non-conformance was initiated to further investigate this complaint.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW EXT DWELL CATH BASIC 22GAX6CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8711833
• MDR Text Key: 148415114
• Report Number: 9680794-2019-00235
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K163513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: EDC-00622-B
• Device Lot Number: 13F18K0331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.