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

Model Number	222002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blister (4537)
Date of Event	06/13/2024
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 the infant's pre wired electrodes were starting to fall off and cause inaccurate readings on the bedside monitor, so the rn removed and replaced the leads.Under the green lead that was removed from infant's left upper abdomen, the rn found 3 new blisters and notified the provider.Photo were taken and uploaded to the patient's chart.The blisters had to be aspirated and cultured.
Event or Problem Description
Per additional information received, the baby was in an incubator (temp 80.1f, 26.7c) prior to the reported incident.Vaseline was applied and the wound was covered in gauze.There was no growth, and no antibiotics were given.The duration of the electrode use is unknown, but they were at least changed in less than 48 hours.
Additional Manufacturer Narrative
A photo sample was provided and show blisters under the area where the electrode was placed.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product.The device was not returned for evaluation; therefore, the reported issue could not be confirmed.This product has been tested according to iso 10993 guidelines for biocompatibility that found both the hydrogel and skin contacting foam adhesive to be non-cytotoxic, non-irritating, and non-sensitizing.The following sections were corrected or completed: section d1 brand name: kendall.Section d3 manufacturer name: cardinal health 200, inc.Section d4 model number: 222002 section d4 unique identifier (udi) #: (b)(4).Section g4 pma/510(k)number: exempt.

• Brand Name: KENDALL
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19629357
• Report Number: 1423537-2024-00052
• Device Sequence Number: 20966203
• Product Code: DRX
• UDI-Device Identifier: 20192253016625
• UDI-Public: (01)20192253016625(17)260301(10)408566X
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: 222002
• Device Catalogue Number: 222002-
• Device Lot Number: 408566X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown