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

Model Number	8888571562
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 4/11/2018.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Customer reports that tubing is detached from the chamber.The liquid in the sterile chamber does reach the level marked in red.Therefore the aspiration is not completed.
Additional Manufacturer Narrative
Submission date: 08/17/2018.An investigation was performed for the reported customer complaint: ¿customer reports that tubing is detached from the chamber.The liquid in the sterile chamber does reach the level marked in red.Therefore the aspiration is not completed.¿ a review of the device history record (dhr) for the reported lot number 17e266fhx indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.A review of changes to product, process, and packaging has been conducted identifying no affecting changes related to this reported event.Control mechanisms are in place for all sentinel seal units to prevent the occurrence and acceptance of the reported condition during the molding, printing, assembly and packaging processes.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, leak/functionality testing, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.One (1) open and used sample was returned for evaluation.The returned sample was heavily contaminated with fluid and blood like substances.The sample received was not decontaminated.Based on the condition of the sample, no testing could be conducted.However, a visual inspection was completed by viewing the sample within the packaging.The reported issue was not and/or unable to be observed.Potential causes of the reported condition include the unit was damaged during transport.The reported customer complaint is not confirmed.A root cause could not be determined.No corrective or preventive action is planned at this time.This complaint will be used for trending purposes.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: 7423188
• Report Number: 9611018-2018-00007
• Device Sequence Number: 18971474
• Product Code: CAC
• UDI-Device Identifier: 20884521061023
• UDI-Public: 20884521061023
• 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): 08/17/2018

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: Health Professional
• Device Expiration Date: 05/25/2022
• Device Model Number: 8888571562
• Device Catalogue Number: 8888571562
• Device Lot Number: 17E266FHX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 08/17/2018
• Patient Sequence Number: 1