MAUDE Adverse Event Report: COVIDIEN SENTINEL SEAL X5; CHEST DRAINAGE UNIT

Model Number 8888571562

Device Problem Air Leak (1008)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10/28/2016.An investigation is currently underway; upon completion the results will be forwarded.

Event Description

It was reported to covidien on 10/26/2016 that a customer had an issue with a chest drainage unit.The customer states the sentinel seal was not air tight and seems to have an air leak.Customer was not able to establish proper vacuum.Sentinel seal was exchanged and new one worked properly.

• Brand Name: SENTINEL SEAL X5
• 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 st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6063160
• MDR Text Key: 59025334
• Report Number: 9611018-2016-00056
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888571562
• Device Catalogue Number: 8888571562
• Device Lot Number: 15L125FHX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1