MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW VESSEL CATH SET: 24 GA X 9CM; CATHETER, PERCUTANEOUS

Catalog Number ES-04650

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges one day after catheter insertion, it was noticed that the cover of the catheter had a leak and did not seal correctly.The catheter was removed and another unit placed.

Manufacturer Narrative

Qn# (b)(4).The customer returned one catheter for evaluation.The catheter contained signs of use.Visual examination did not reveal any defects or anomalies.The returned catheter measured 3.35" which is within specification.The returned catheter was functionally tested by injecting water using a lab inventory syringe.Water exited the distal end of the catheter as expected.The catheter was then tested by connecting the catheter to a leak tester and clamping off the distal end of the catheter.The leak tester was turned on and the pressure was increased to 300 kpa and held for 30 seconds.No leaks were observed from any region of the catheter.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with this kit cautions the user, "do not suture directly to outside diameter of catheter to minimize the risk of cutting or damaging the catheter or impeding catheter flow." the reported complaint of catheter leaking in use could not be confirmed by complaint investigation.The returned catheter passed all relevant dimensional and functional testing.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.No problem was found with the returned sample.

Event Description

The customer alleges one day after catheter insertion, it was noticed that the cover of the catheter had a leak and did not seal correctly.The catheter was removed and another unit placed.

• Brand Name: ARROW VESSEL CATH SET: 24 GA X 9CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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 ; 9194334854
• MDR Report Key: 7259680
• MDR Text Key: 99915842
• Report Number: 3006425876-2018-00105
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: ES-04650
• Device Lot Number: 71F16J0743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2016
• 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
• Patient Age: 1 DA