MAUDE Adverse Event Report: COVIDIEN 30318 AQUA-SEAL CDU; CHEST DRAINAGE UNIT

Model Number 8888571299

Device Problems Leak/Splash (1354); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on 02/22/2017 that a customer had an issue with a chest drainage unit.The physician reports that the product had leak and it did not seal completely, the patient did not have injuries or health issues.Per follow up information received on 2/22/17, the reported leak was in the water seal chamber.

• Brand Name: 30318 AQUA-SEAL CDU
• Type of Device: CHEST DRAINAGE UNIT
• Manufacturer (Section D): COVIDIEN; sragh industrial estate; county offaly; tullamore ; EI
• Manufacturer (Section G): COVIDIEN; sragh industrial estate; county offaly; tullamore ; EI
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6360185
• MDR Text Key: 68754883
• Report Number: 9611018-2017-00002
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 15E358FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1