MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. NON COATED PNCL BTN HLSTR; NON COATED PENCIL BUTTON HOLSTER

Catalog Number	0039H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: 1 each 0039h lot number 1711155 was returned for evaluation.During visual inspection under magnification a brownish smudge was found on the inside of the pouch surface.Located above the holster.This substance exceeds specification of 0.40 mm2 in size.The complaint is confirmed.The dhr review of the reported lot number (1711155) confirmed that the product was produced accomplishing quality requirements and released according to established procedures.
Event or Problem Description
It was reported by the sales rep that, there was a foreign matter in each package of 0037h and 0039h.The device was not used for the patient.Another device was used to complete the case.There were no adverse consequences to the patient.One 0037h and one 0039h will be returning.No further information is available.Affiliate reference number: (b)(4).Potential voc: packaging foreign matter.

• Brand Name: NON COATED PNCL BTN HLSTR
• Common Device Name: NON COATED PENCIL BUTTON HOLSTER
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9266289
• Report Number: 1721194-2019-00129
• Device Sequence Number: 11436706
• Product Code: GEI
• UDI-Device Identifier: 10614559100868
• UDI-Public: 10614559100868
• 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): 10/03/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 0039H
• Device Lot Number: 1711155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 11/01/2019
• Patient Sequence Number: 1