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

Model Number 8888571562

Device Problems Bent (1059); No Device Output (1435)

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

Event Date 04/29/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date 5/6/2016.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a chest drainage unit.The customer states that the rings on the tube that prevents the tube from bending was stuck too high.The tube was bent and the liquids were not able to evacuate to the canister.

Manufacturer Narrative

Because a sample was not received, we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).Unfortunately, without a sample we are unable to confirm the reported condition.If a sample should be returned at a later date this complaint will be reopened and the investigation updated to reflect our findings.As no lot number was identified in the complaint report a review of the device history record (dhr) could not be carried out.There was a photo attached to the complaint which shows the tube is not connected correctly.A potential root cause for this complaint may be that the sleeve was not inserted fully or dislodged post production.A quality alert was initiated to communicate and create understanding of this customer concerns to all personnel involved in the manufacturing of this product.Furthermore, a formal corrective and preventative action investigation has been initiated to investigate complaints for the tubing issues.No further action is required at this time.The complaint will be used for tracking and trending purposes.

• 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: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5637173
• MDR Text Key: 45000660
• Report Number: 9611018-2016-00011
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: LU
• 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,Followup
• Report Date: 04/29/2016

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 Model Number: 8888571562
• Device Catalogue Number: 8888571562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/29/2016
• Initial Date FDA Received: 05/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1