MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. NON COATED NEEDLE 2.75IN; NON COATED NEEDLE 2.75 INCH

Catalog Number	0313
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.
Event or Problem Description
It was reported that the customer ordered product code 0313 but when the box was opened product code 0313m was inside the box.It is unknown if this was during a procedure and there were no patient consequences reported.

• Brand Name: NON COATED NEEDLE 2.75IN
• Common Device Name: NON COATED NEEDLE 2.75 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 7765238
• Report Number: 1721194-2018-00028
• Device Sequence Number: 16461747
• Product Code: GEI
• UDI-Device Identifier: 10614559101568
• UDI-Public: 10614559101568
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K973346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2018

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 Catalogue Number: 0313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/08/2018
• Patient Sequence Number: 1