MAUDE Adverse Event Report: COVIDIEN CADENCE PHYSIO PRECONNECT; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number	22550PC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The cardinal health sales representative reported that when checking her inventory of medi-trace cadence pre-connect defibrillation electrodes, she found that when peeling off the backing sheet of the pad, the gel comes away.
Additional Manufacturer Narrative
H 3 evaluation summary: the device history record (dhr) was reviewed and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process, this testing includes peel testing to inspect for delamination.Samples were received in the form of an open pouch of product.A photo of the issue was also returned as part of the complaint report.The sample returned showed a minor amount of delamination.Retain samples were pulled for the reported lot and the samples showed no signs of gel delamination.Retain samples from the sub-assembly gel bodies were inspected and no gel delamination was seen.From a root cause analysis perspective, gel delamination occurs when the gel-to-release liner bond strength is greater than the cohesive strength of the gel or greater than the gel-to-substrate bond strength.Such an inequity in bond strength can cause the gel to peel from the substrate and/or tear.Proper storage and usage of the electrodes is critical to the performance of the gel.The electrodes should be stored in their sealed, foil lined pouches away from extreme heat and humidity.Failure to ensure product is stored correctly can affect the product and result in issues with the gel.The exact root cause of the issue was not able to be determined from the investigation.No corrective or preventative actions are necessary as this is a known and aesthetic issue.The manufacturing site will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: CADENCE PHYSIO PRECONNECT
• Common Device Name: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 9897200
• Report Number: 1219103-2020-00279
• Device Sequence Number: 2437999
• Product Code: DRO
• UDI-Device Identifier: 20884527022325
• UDI-Public: 20884527022325
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/03/2020

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: No Information
• Device Model Number: 22550PC
• Device Catalogue Number: 22550PC
• Device Lot Number: 912034X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 06/03/2020
• Patient Sequence Number: 1