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

Model Number N/A

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

No information was provided.The customer reported the following lot #'s may be have been associated with this incident; 2021-09 eu, 2021-09 et, 202105 fd, 202110 fg & 202109 ey.Reported lot #s expiration date information requested.Waiting on this information.Reported lot #s manufacture date information requested.Waiting on this information.The sample has been received for evaluation.Analysis is pending.A device history review (dhr) was requested for the reported lot #s.A supplemental report will be sent upon sample evaluation completion.

Event Description

A hospital employee 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.No patient injury was alleged.

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.

• Brand Name: RED DOT¿
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M CANADA COMPANY; 400 route 100; morden, R6M 1 Z9; CA R6M 1Z9
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 9489787
• MDR Text Key: 175881161
• Report Number: 2110898-2019-00152
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10707387463356
• UDI-Public: 10707387463356
• 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: company representative,health
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 2570-5
• Device Lot Number: 2021-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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