MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW DRAINAGE SET; CATHETER IRRIGATION

Catalog Number AI-01600

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the doctor inserted a cavity drain on a patient in the cardiac ward.When cavity drain connected, they found it leaking at one of the connection tubing.The doctor removed the cavity drain and opened another one (same item).Doctor inserted the new cavity drain and it worked fine.

Manufacturer Narrative

(b)(4).Customer returned a drainage catheter and lidstock for evaluation.Initial visual inspection did not reveal and defects or anomalies on the catheter.After the catheter failed functional testing, microscopic inspection revealed a small cut in the proximal extension line.The appearance of the cut was consistent with when the extension line comes in contact with a sharp instrument (i.E.Scalpel, scissors, etc.).The overall length and inner and outer diameter of the extension line were measured and all were found to be within specification.After the distal tip was occluded and the drainage tube was blocked with a gloved thumb, a 10ml syringe was connected to the extension line and the catheter was pressurized.Water could be seen leaking out of the small cut in the extension line just above the connection point.A dhr review was completed with no relevant findings.The ifu provided with this kit warns the user "do not suture directly to outside diameter of catheter to minimize the risk of cutting or damaging catheter or impeding catheter performance." the ifu also cautions the user "to minimize the risk of cutting catheter do not use scissors to remove dressing".The customer report of a leak was confirmed by complaint investigation.The proximal extension line contained one small cut/tear near the connection point of the extension line to the drainage tube.The slit was consistent with the catheter being damaged by a sharp object (i.E.Scalpel, scissors, etc.).A device history record review was completed with no relevant findings and all relevant dimensional measurements were within specification.Based on the appearance of the damage and the customer report that the defect was identified during use, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that the doctor inserted a cavity drain on a patient in the cardiac ward.When cavity drain connected, they found it leaking at one of the connection tubing.The doctor removed the cavity drain and opened another one (same item).Doctor inserted the new cavity drain and it worked fine.

• Brand Name: ARROW DRAINAGE SET
• Type of Device: CATHETER IRRIGATION
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8691965
• MDR Text Key: 147753690
• Report Number: 9680794-2019-00232
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: K895516
• 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: 05/21/2019

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: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: AI-01600
• Device Lot Number: 13F18H0405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 06/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1