MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RED DOT¿ NEONATAL, PRE-WIRED, RADIOLUCENT MONITORING ELECTRODE WITH CLEAR TA; ELECTROCARDIOGRAPHIC ELECTRODE, SINGLE-USE

Model Number 2269T

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Purulent Discharge (1812); Erythema (1840); Rash (2033); Skin Tears (2516); Blister (4537); Swelling/ Edema (4577)

Event Date 10/12/2022

Event Type  Injury  

Event Description

A 2-week-old female experienced left chest/axillary erythema, edema, rash, skin tears, maceration, purulent drainage and a 3cm x 6cm blister, less than 24-hours post application of 3m¿ red dot¿ neonatal, pre-wired, radiolucent monitoring electrode with clear tape, 2269t lot 202407ab.Medical treatment was reportedly required and was noted as wound care.Exufiber® ag+ with hydrolock® and allevyn silicone dressings were applied for 4 days, as the blisters drained the purulent fluid.Subsequently, the allevyn silicone dressings were utilized for 3 additional days.The symptoms reportedly resolved after 5 days.

Manufacturer Narrative

Patient identifier: not available.A sample was not returned.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 determine the root cause of the alleged injury or whether an electrode was the root cause.This is an on-going low-level issue which was identified through customer complaints.Multiple studies are regularly conducted that have demonstrated appropriate device biocompatibility and safety performance criteria when the device is used appropriately on humans.Known failure modes include allergies and sensitivities to adhesives or other components and incorrect use of product.

• Brand Name: 3M¿ RED DOT¿ NEONATAL, PRE-WIRED, RADIOLUCENT MONITORING ELECTRODE WITH CLEAR TA
• Type of Device: ELECTROCARDIOGRAPHIC ELECTRODE, SINGLE-USE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M CANADA COMPANY; 400 route 100; morden, manitoba R6M 1 Z9; CA R6M 1Z9
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 15916126
• MDR Text Key: 304813192
• Report Number: 2110898-2022-00121
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 30707387140923
• UDI-Public: 10707387140929
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2269T
• Device Catalogue Number: 2269T
• Device Lot Number: 202407AB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 WK
• Patient Sex: Female
• Patient Weight: 3 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White