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

Model Number 8888571562

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2018

Event Type  malfunction  

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 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.

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
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): COVIDIEN; sragh industrial estate,rahan; tullamore
• Manufacturer (Section G): COVIDIEN; sragh industrial estate,rahan; tullamore
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7423188
• MDR Text Key: 105243621
• Report Number: 9611018-2018-00007
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 20884521061023
• UDI-Public: 20884521061023
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1