MAUDE Adverse Event Report: CARDINAL HEALTH 1050NPSM KCAT 3/PK 100 PK/CASE; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	31424768
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	09/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the electrode was removed from the skin leaving behind a small 2x2cm skin abrasion which was oozing.Per additional information received, the baby had pus like fluid draining from the affected site.Initial care of a saline clean and a comfeel covering was given.The pediatrician prescribed bactroban ointment in the hospital and the baby went home fully healed.There was no medical procedure for the skin lesion.The duration of use of the electrode was for about 2 days.
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

• Brand Name: 1050NPSM KCAT 3/PK 100 PK/CASE
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CARDINAL HEALTH; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• MDR Report Key: 12668704
• Report Number: 9681860-2021-00523
• Device Sequence Number: 11802674
• Product Code: DRX
• UDI-Device Identifier: 20884527005007
• UDI-Public: 20884527005007
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Report Date (Section B): 10/20/2021

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
• Operator of Device: No Information
• Device Expiration Date: 01/08/2022
• Device Model Number: 31424768
• Device Catalogue Number: 31424768
• Device Lot Number: 101855X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/20/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other