MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN NEEDLE MOD 2.75IN; E-Z CLEAN NEEDLE MODIFIED 2.75 INCH

Model Number	0013M
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Investigation summary: as the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The lot/batch/serial number was not provided; therefore, a manufacturing record evaluation could not be performed.Additional information was requested, and the following was obtained: no patient adverse consequences were reported.It is not a problem of 0035, but a problem when using 0013m product with 0035h.The insulation of the insulated part was peeled off, and replaced with a new tip.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during an unknown procedure, the 0013m was being used with the conmed 2450 & 0035h pencil.The insulation part of 0013m broke.The generator power at that time was 40w.There were no patient consequences.

• Brand Name: E-Z CLEAN NEEDLE MOD 2.75IN
• Common Device Name: E-Z CLEAN NEEDLE MODIFIED 2.75 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 10459459
• Report Number: 1721194-2020-00045
• Device Sequence Number: 19651630
• Product Code: GEI
• UDI-Device Identifier: 10614559100134
• UDI-Public: 10614559100134
• Combination Product (Y/N): N
• PMA/510(K) Number: K081791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0013M
• Device Catalogue Number: 0013M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1