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

Model Number 8888571299

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

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

Event Date 04/04/2016

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 chest drainage unit.The customer states the collection tube was loose and disconnected from the device.

Manufacturer Narrative

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.There were photos attached to the complaint which show the tube disconnecting from the unit however the actual root cause could not be determined from the photos.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 issue.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.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 this lot.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: 5574309
• MDR Text Key: 43189187
• Report Number: 9611018-2016-00007
• 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: 04/04/2016

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: 15D115FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2016
• Initial Date FDA Received: 04/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 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