MAUDE Adverse Event Report: COVIDIEN SENTINEL SEAL; APPARATUS, AUTOTRANSFUSION

Model Number	8888571513
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 01/12/2018.An investigation is currently underway.Upon completion, the results will be forwarded.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states that the chest drainage unit arrived broken with kinked tubing.
Additional Manufacturer Narrative
An investigation into the reported condition was performed.Although the complaint report states that a sample has been requested and would be returned no sample has been received at the manufacturing site.Without a sample, we are unable to perform a thorough follow up investigation to include functional and visual evaluation.The reported condition is not confirmed.The review of device history records (dhr) indicates that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of the reported lot.A probable root cause of this reported condition may be that the kink was caused during the storage process for the tubes prior to assembly or that the operator coiled the tube incorrectly thus causing a kink or the kink occurred in the tubing during the transport.A definitive root cause of the reported condition could not be determined without a sample.Therefore, a corrective action could not be planned at this time.If a sample should be returned at a later date this complaint will be reopened and the investigation updated to reflect our findings.During the manufacturing of all units, they are all leak tested and functionally tested as a part of the process.Also, independent sampling is complete to confirm units are functioning correctly.Before wrapping and packing, the tube is coiled and covered with a packing cap.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SENTINEL SEAL
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): COVIDIEN; sragh industrial estate,rahan; tullamore
• MDR Report Key: 7186824
• Report Number: 9611018-2018-00001
• Device Sequence Number: 1066715
• Product Code: CAC
• UDI-Device Identifier: 20884521073262
• UDI-Public: 20884521073262
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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
• Operator of Device: Other
• Device Expiration Date: 04/10/2022
• Device Model Number: 8888571513
• Device Catalogue Number: 8888571513
• Device Lot Number: 17D096FHX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 03/15/2018
• Patient Sequence Number: 1