MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KENDALL; CABLE, ELECTRODE

Model Number	33506
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that one (1) each of the ge adapter sku 33506's internal green and white plastic molding has melted and come apart from the pink casing.Additional information received on 09jul2025 stated that only 33506 is affected.Unfortunately, they had no lot # nor a sample.They said it happened a while ago and only had a picture.It is not known how long it's been used.The rep is not aware of any heating issues with the product or monitor during use or when this adapter is connected to the monitor socket.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.Thirty retained samples underwent cosmetic inspection; no issues were found.The complaint sample was not returned for evaluation however a photo was provided and the reported issue was observed.Based on the available information, a root cause could not be determined at this time.¿ ¿we will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: KENDALL
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 22564263
• Report Number: 1423537-2025-00288
• Device Sequence Number: 9283146
• Product Code: IKD
• UDI-Device Identifier: 10884527021468
• UDI-Public: 10884527021468
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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
• Device Model Number: 33506
• Device Catalogue Number: 33506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/22/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown