MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLN PNCL BTN MOD BLD HLSTR; E-Z CLEAN PENCIL BTN MOD BLADE HOLSTER

Catalog Number	0037H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: 2 each 0037h lot 191107 in unopened pouches were received for evaluation.During visual inspection of first sample found a brown embedded contaminate on the outer edge of the holster which exceeds specification of 0.40 mm2.Second sample no contamination/particulate found.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 that there was a foreign matter in the package.It was also reported that the package was damaged.The devices were not used for the patient.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Brand Name: E-Z CLN PNCL BTN MOD BLD HLSTR
• Common Device Name: E-Z CLEAN PENCIL BTN MOD BLADE HOLSTER
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9267270
• Report Number: 1721194-2019-00131
• Device Sequence Number: 16698545
• Product Code: GEI
• UDI-Device Identifier: 10614559101674
• UDI-Public: 10614559101674
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/07/2019

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: 03/31/2024
• Device Catalogue Number: 0037H
• Device Lot Number: 191107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 11/01/2019
• Patient Sequence Number: 1