MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ELECTRODE,ECG,TAB,10/CARD,5000/CS, SMALL

Catalog Number	MDSM616101
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the electrodes came out defective, they adhesive is not working as it should.There is missing adhesive on the length of the tab.".
Additional Manufacturer Narrative
The customer reported that the electrodes came out defective, the adhesive is not working as it should, and there is missing adhesive on the length of the tab.Medline received 1bx in like-new condition, performed a visual inspection, and then performed functional testing by applying ten total resting tab electrodes on arms and removing them after 5 minutes; the electrodes appeared to have less adhesive than normal and did not stick well to the skin.The complaint was confirmed.The issue shown via investigation was most likely caused due to inadequate adhesive applied during the manufacturing process; the vendor was notified, material trending showed no similar complaints during the last 12 months, and the division was informed and will continue to monitor trends.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: ELECTRODE,ECG,TAB,10/CARD,5000/CS, SMALL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50946454
• Report Number: 1417592-2026-54261
• Device Sequence Number: 9534651
• Product Code: DRX
• UDI-Device Identifier: 40888277352323
• UDI-Public: 40888277352323
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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
• Device Catalogue Number: MDSM616101
• Device Lot Number: 85921120002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown