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

Model Number	0038H
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of event: unknown; captured as awareness date.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 dhr review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.Was the open inner box compromised of the sterility of the device? no further information will be available.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 when the device arrived, the inner box was opened.The blade tip was not broken off and no pieces fell into the patient.There were no adverse consequences to the patient.No further information is available.

• Brand Name: NON COATED PNCL RKR HLSTR
• Common Device Name: NON COATED PENCIL ROCKER HOLSTER
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 11357743
• Report Number: 1721194-2021-00012
• Device Sequence Number: 2564993
• Product Code: GEI
• UDI-Device Identifier: 10614559100844
• UDI-Public: 10614559100844
• Combination Product (Y/N): N
• PMA/510(K) Number: K965054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2021

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: 01/31/2025
• Device Model Number: 0038H
• Device Catalogue Number: 0038H
• Device Lot Number: 1911102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2021
• Initial Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1