MAUDE Adverse Event Report: 3M HEALTH CARE MEDICAL SOLUTIONS DIVISION 3M¿ RED DOT¿ NEONATAL LIMB BAND MONITORING ELECTRODE, PRE-WIRED; ELECTROCARDIOGRAPHIC ELECTRODE

Catalog Number	2284
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Burn(s) (1757)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1 - a6: not provided.D4: lot number and expiration date: not available.H4: manufacture date: not available.H10: product sample was not returned to 3m for analysis.Without a sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to definitively determine the root cause.The instructions for use states, for 3m¿ red dot prewired limb band ecg monitoring electrode: precautions: do not wrap the limb band too tightly or restrict blood flow.Check circulation.To prevent dry out, do not store electrodes out of the bag.Do not use an electrode if the conductive adhesive is dry and no longer sticky.Do not use an electrode if any part of the lead wire is detached from the electrode.Do not prepare neonate and infant skin with alcohol or an abrader to minimize skin irritation.For proper skin management and to minimize skin irritation: avoid placing an electrode on an irritated skin site.Avoid removing electrodes frequently and/or reapplying to the same skin site.Assess electrode sites periodically.
Event or Problem Description
A hospital risk manager reported a neonate allegedly experienced a 10mm x 10mm localized skin burned/bruised with a purple/red appearance with the use of the 3m¿ red dot¿ ecg monitoring electrodes, neonatal, pre-wired, limb band, 2284.The wire to the lead was reportedly not connected to the adhesive portion, appeared frayed, and was "stuck" to the patient's skin.No medical intervention was reported.

• Brand Name: 3M¿ RED DOT¿ NEONATAL LIMB BAND MONITORING ELECTRODE, PRE-WIRED
• Common Device Name: ELECTROCARDIOGRAPHIC ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE MEDICAL SOLUTIONS DIVISION; 3m center, building 275-5w-06; 2510 conway ave; st. paul MN 55144 1000
• Manufacturer (Section G): LUDLOW TECHNICAL PRODUCTS CANADA LTD.; 215 herbert street; gananoque, ontario K7G 2 Y7; CA K7G 2Y7
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 17653215
• Report Number: 2110898-2023-00082
• Device Sequence Number: 17706419
• Product Code: DRX
• UDI-Device Identifier: 50707387468571
• UDI-Public: 50707387468571
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/30/2023

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: Health Professional
• Device Catalogue Number: 2284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown