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

Model Number 8888571299

Device Problem Disconnection (1171)

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

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 08/29/2016.An investigation is currently underway; 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 the tube was disconnected from the base unit at the corrugated area.Surgeon connected a new system.No injury to the patient at present.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was release accomplishing all quality standards.The complaint report states that a sample would be returned and a sample request letter was sent out, the sample was returned to the decontamination site but on review of the sample it was decided not to forward it onto the manufacturing site as the sample contained a lot of blood or a blood-like substance inside and outside the aqua seal and the site were not sure if they would be able to completely clean out the inside and there is a lot of bio hazardous material on the sample.The site took photos of the sample which shows the tube is disconnected.Without a physical sample 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, 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 corrective action (capa) has been initiated to investigate complaints for the tubing issues.Based on the above no further action is required at this time.This complaint will be used for qa tracking and trending purposes.

• 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): COVIDEIN; sragh industrial estate; county offaly; tullamore ; EI
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5910569
• MDR Text Key: 54217922
• Report Number: 9611018-2016-00043
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 08/18/2016

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: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 14A219FHX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 08/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/21/2016
• 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