MAUDE Adverse Event Report: 3M HEALTH CARE RED DOT¿; ECG ELECTRODE

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned complaint samples and plant retains were tested and exceeded the minimum requirements for stud pull testing.No adverse trend was observed for this issue.3m will continue to monitor.
Additional Manufacturer Narrative
No information was provided.Reported lot # expiration date information requested.Waiting on this information.Reported lot # manufacture date information requested.Waiting on this information.Product samples were received for evaluation.Analysis is pending.A device history review (dhr) was requested for the reported lot #.A supplemental report will be sent upon returned product evaluation completion.
Event or Problem Description
A nurse manager reported that 3m¿ red dot¿ monitoring electrodes with foam tape and sticky gel, model 2570-5, are frequently getting stuck in the lead wires after they are used.Phillips¿ monitors and lead wires are used by the facility.The nurse manager reported the staff has been unable to remove the black portion of the red dot¿ electrodes from the leads, at times, and the 5 lead ekg wires are unusable.

• Brand Name: RED DOT¿
• Common Device Name: ECG ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 9419419
• Report Number: 2110898-2019-00145
• Device Sequence Number: 2579120
• Product Code: DRX
• UDI-Device Identifier: 10707387463356
• UDI-Public: 10707387463356
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 2570-5
• Device Lot Number: 2021-05 FD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1