MAUDE Adverse Event Report: CONVERTORS DE MEXICO, S.A. DE C.V. EP TRAY (EPHMD)105; GENERAL SURGERY TRAY (KIT)

Model Number	SAN11EPHME
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the customer information submitted, the staff member was cut by the halstead mosquito forcep sm161 that was sticking through the surgical pack on (b)(6) 2017.The staff member went to occupational medicine per hospital procedure and received a tetanus shot as a precautionary measure because he could not recall when he had had one last.All production process systems were reviewed and no discrepancies were found.This wo # (b)(4) was for (b)(4) kits and it was manufactured in lines (b)(6) and (b)(6) on (b)(6) 2017.(b)(4) kits were inspected by the production team with no defects found.(b)(4) kits were inspected by the qa team with no defects found.No rts or a/p for this component.The investigation was completed.The pack design of wo# (b)(4) was evaluated by the design team.The picture provided and the design of the kit were reviewed and we found a risk for the btc # (b)(4) to be punctured by the sharp component items # (b)(4), sm106 & sm161 since they are into a zip lock bag near to the btc.The kit was flagged for design change on (b)(6) 2017 to look for a safer placement for the sharp components and these components will be protected with soft components to avoid any damage to the btc.
Event or Problem Description
Based on the customer information submitted, the staff member was cut by the halstead mosquito forcep sm161 that was sticking through the surgical pack.The staff member went to occupational medicine per hospital procedure and received a tetanus shot as a precautionary measure because he could not recall when he had had one last.

• Brand Name: EP TRAY (EPHMD)105
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): CONVERTORS DE MEXICO, S.A. DE C.V.; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 7002862
• Report Number: 1423537-2017-00138
• Device Sequence Number: 939431
• Product Code: LRO
• UDI-Device Identifier: 10887488119793
• UDI-Public: 10887488119793
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SAN11EPHME
• Device Catalogue Number: SAN11EPHME
• Device Lot Number: 750378
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other