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

Model Number 8888571299

Device Problem Detachment Of Device Component (1104)

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

Event Date 03/18/2016

Event Type  Injury  

Manufacturer Narrative

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 hose is detached from the system.

Manufacturer Narrative

Submit date 04/14/2016.Additional information was reported to covidien on 04/08/2016.The customer states the hose became detached from the system.This caused a pneumothorax.The hose that detached is the hose going to the patient from the cdu.It detached from the top of the cdu.

Manufacturer Narrative

Submit date: 05/24/2016.An investigation of the reported condition was performed.There has been no sample returned to the manufacturing facility so a root cause investigation could not be completed.A possible root cause may be that the patient tube was not fully pushed down on the suction port.A test was completed using 30 assembled units to measure the force required to remove the patient tube when it is fully pushed down on the suction port.The results show that a force of over 30kg is actually required to pull the patient tube where the minimum specification is 4.54kg.A quality alert was initiated to communicate this complaint to the manufacturing team and to ensure the patient tube is fully pushed down over the suction port.Previous similar complaints for this product have provided us with information and another probable root cause for this reported condition.The site has received information that the product in question is being shipped in quantities of one (1).Ship/shake transit testing for these products has been approved based on a quantity of 5 units per carton as is presented from the manufacturing site.Product damage will occur if this product is broken down into "eaches." therefore the probable root cause of the reported condition is that the product was damaged during transit.As no lot number was identified in the complaint report, a review of the device history record (dhr) could not be carried out.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: CHEST DRAINAGE UNIT
• Manufacturer (Section D): COVIDIEN; sragh industrial estate; county offaly; tullamore ; EI
• Manufacturer (Section G): COVIDIEN; sragh industrial estate; co. offaly; tullamore ; EI
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5543892
• MDR Text Key: 42094402
• Report Number: 9611018-2016-00005
• 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,Followup
• Report Date: 03/18/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/14/2016; 05/24/2016
• 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