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

Catalog Number AI-01600

Device Problems Difficult to Insert (1316); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: the doctor (cardio thoracic surgeon) attempted to insert the percutaneous cavity drain x2 unsuccessfully.Dr.Verbalized that there was a problem with the tip of the 14fr catheter.

Event Description

The customer reports: the doctor (cardio thoracic surgeon) attempted to insert the percutaneous cavity drain x2 unsuccessfully.Dr.Verbalized that there was a problem with the tip of the 14fr catheter.

Manufacturer Narrative

(b)(4).The customer returned the product lidstock for evaluation.None of the components from the kit were returned.Visual examination of the lidstock confirmed the part number and lot number matched what was reported by the customer.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 product describes suggested techniques for catheter insertion to mitigate risk of damaging the catheter.The ifu also contains the warning "alcohol and acetone can weaken the structure of polyurethane material.Therefore, care should be taken when instilling drugs containing alcohol or when using high concentration of alcohol or acetone when performing routine catheter care and maintenance." the customer report of a damaged catheter tip could not be confirmed.Only the product lidstock was returned, none of the components were returned for evaluation.A device history record was performed and no relevant manufacturing issues were identified.Without the actual device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW DRAINAGE SET
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7309341
• MDR Text Key: 101373877
• Report Number: 3003737899-2018-00020
• 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: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: AI-01600
• Device Lot Number: 13F17B0052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Date Manufacturer Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR