MAUDE Adverse Event Report: TULLAMORE 30318 AQUA-SEAL CDU; CONNECTOR TUBE

Model Number 8888571299

Device Problems Kinked (1339); Connection Problem (2900)

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

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 (b)(6) 2016 that a customer had an issue with a connector tube.The customer reports that the corrugated tube does not fit properly to the canister, it kinks.

Manufacturer Narrative

Submit date: 07/25/2016.One sample was received at the site and the reported has been confirmed.A potential root cause for this issue may be that the sleeve was not inserted fully or dislodged post production.A quality alert was initiated to communicate and create understanding of the customer's concern to all personnel involved in the manufacturing of this product.Quality inspections have been increased to detect this issue.Furthermore a formal corrective and preventative action (capa) has been initiated to investigate complaints for tubing issues.The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of lot 16a108fhx.Based on the above no further action is required at this time.The associated data will be fed into the risk management quarterly report.

• Brand Name: 30318 AQUA-SEAL CDU
• Type of Device: CONNECTOR TUBE
• Manufacturer (Section D): TULLAMORE; sragh industrial estate; county offaly; tullamore ; EI
• Manufacturer (Section G): COVIDIEN; sragh industrial estate; county offaly; tullamore ; EI
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5768934
• MDR Text Key: 48773335
• Report Number: 9611018-2016-00026
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 07/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• 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: 16A108FHX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1