MAUDE Adverse Event Report: COOK COOK MAC LOC CHEST TUBE

Model Number MAC LOC CHEST TUBE

Device Problem Break (1069)

Patient Problem Pneumothorax (2012)

Event Date 01/25/2017

Event Type  malfunction  

Event Description

Cook mac-loc chest tube lot # 7486055, broke during placement in pt x 2.First tube was placed on (b)(6) 2017, pt developed pneumothorax.Second tube insertion on (b)(6) 2017, broke (b)(6) 2017.All tubes displaying the make and lot number have been sequestered and sent back to the reps by the ir staff.

• Brand Name: COOK MAC LOC CHEST TUBE
• Type of Device: CHEST TUBE
• Manufacturer (Section D): COOK
• MDR Report Key: 6313797
• MDR Text Key: 67173685
• Report Number: MW5067761
• Device Sequence Number: 2
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/07/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MAC LOC CHEST TUBE
• Device Lot Number: 7486055
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1