MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN PNCL RKR HLSTR; E-Z CLEAN PENCIL ROCKER HOLSTER

Model Number	0030H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 1/15/2020.Batch #unk.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
Event or Problem Description
It was reported by the sales rep that, during an unknown procedure, the device kept vibrating although the activation switch was not pressed during use.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Investigation summary: one each 0030h lot 1708017 was received for evaluation.During visual inspection observed excessive blood on the device including the entire cable.The pencil was functionally tested and found to be performing within specifications and no self activation was found.Opened the pencil housing to examine the internal components.Found dried blood inside the nose of the pencil and next to the internal components.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis as no self activation was found.

• Brand Name: E-Z CLEAN PNCL RKR HLSTR
• Common Device Name: E-Z CLEAN PENCIL ROCKER HOLSTER
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9594114
• Report Number: 1721194-2020-00014
• Device Sequence Number: 3650523
• Product Code: GEI
• UDI-Device Identifier: 10614559100479
• UDI-Public: 10614559100479
• Combination Product (Y/N): N
• PMA/510(K) Number: K965054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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 Expiration Date: 03/31/2023
• Device Model Number: 0030H
• Device Catalogue Number: 0030H
• Device Lot Number: 1708017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 03/04/2020
• Patient Sequence Number: 1