MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ECG ELECTRODES NEONATAL 1.5MM RADIOTRANSLUCENT; MEDLINE ELECTROSURGICAL ELECTRODE KIT

Catalog Number MDS61115R

Device Problems Failure To Adhere Or Bond (1031); Break (1069)

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

Event Date 07/27/2016

Event Type  malfunction  

Event Description

A new package of ecg electrodes with a broken white lead.The wire was apart from the adhesive for the patient.

• Brand Name: ECG ELECTRODES NEONATAL 1.5MM RADIOTRANSLUCENT
• Type of Device: MEDLINE ELECTROSURGICAL ELECTRODE KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl.; mundelein IL 60060
• MDR Report Key: 6102958
• MDR Text Key: 59936287
• Report Number: 6102958
• Device Sequence Number: 1
• Product Code: NWI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: MDS61115R
• Device Lot Number: 160220
• Other Device ID Number: 10884389114872
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1