MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KENDALL; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	31424785
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that a burn occurred on one of their micro preemies.The leads they use are cardinal health kendall 1051npsm neonatal electrodes.They are pre-wired, small cloth and radiolucent.The baby has healed but seems to have a mark now.The patient was prescribed bactroban.
Additional Manufacturer Narrative
Physical samples were not received for the investigation; however, photos were received.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual evaluation of the photo sample, the reported issue was confirmed; it appeared to show some form of burn/skin irritation that formed where the electrode was in use.Actions have been taken to address the reported condition.A quality alert was also issued to alert for gel awareness.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
**udi related data quality updates only** corrected section d1 brand name; corrected section d3 manufacturer name; corrected section d4 unique identifier (udi) #; corrected section g4 pma/510(k)number; corrected section h4 device manufacture date; corrected section h5 labeled for single use?.

• Brand Name: KENDALL
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17924898
• Report Number: 9681860-2023-00533
• Device Sequence Number: 2982800
• Product Code: DRX
• UDI-Device Identifier: 20192253017356
• UDI-Public: (01)20192253017356(17)240404(10)221325X
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 31424785
• Device Catalogue Number: 31424785
• Device Lot Number: 206335X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 09/27/2023; Not provided
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 01/23/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown