MAUDE Adverse Event Report: COVIDIEN MEDI-TRACE CADENCE

Model Number	22660PC
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 3/24/2017.An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reports gel pulls off and is removed from pad when plastic backing is removed.
Additional Manufacturer Narrative
A complaint sample was received in the form of 1 defib electrodes and one pouch from the customer.The pouch indicated production lot number 611345x.Upon visual inspection of the electrodes gel delamination from the substrate was observed along the edge of one of electrodes in one location for each of the sets.The other electrode pad within each set had no delamination.The degree of delamination was evaluated on the complaint sample per manual single directional peel requirements in the quality lab as part of the investigation.The degree of gel separation/delamination was determined as follows: one electrode pad had delamination at 6.1% and the other was 0%.The delamination did extend into the silver printed area, however it did not include conductive mat area.All of the gel delamination was within 45% maximum hydrogel separation from the adult electrode criteria.Four (4) production retains were reviewed as well.None of the production retains exhibited delamination.The results of the testing, pictures of returned sample showing the condition of the electrodes and the delamination observed are attached.A picture of the customer returned sample is attached along with a copy of the test results for the customer return sample and production retains.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDI-TRACE CADENCE
• Manufacturer (Section D): COVIDIEN; 2 ludlow park dr; chicopee MA 01022 1318
• MDR Report Key: 6432801
• Report Number: 1219103-2017-05004
• Device Sequence Number: 11138709
• Product Code: DRO
• UDI-Device Identifier: 20884521140919
• UDI-Public: 20884521140919
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2018
• Device Model Number: 22660PC
• Device Catalogue Number: 22660PC
• Device Lot Number: 611345X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: 02/24/2017
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1