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	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported that during a hernia repair procedure upon opening the device which should have had part number 0313 instead had 0313m inside.Two other devices were opened with the same incorrect 0313m part inside.An alternate lot# with the correct part inside was used to complete the procedure.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/16/2018.Investigation summary: received 8 each of lot 176478.During visual inspection, found the incorrect part was manufactured for the product id.The product is actually a 0313m but should have been a 0313.A review of the dhr shows this product was originally manufactured to specifications and there is no evidence of device defect or malfunction.

• 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: 7579521
• Report Number: 1721194-2018-00013
• Device Sequence Number: 1775502
• Product Code: GEI
• UDI-Device Identifier: 10614559101551
• UDI-Public: 10614559101551
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 05/15/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1