MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE EYE PACK (EYDCD)144; GENERAL SURGERY TRAY (KIT)

Model Number	SEY2DEYDCE
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/1980
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Customer informed cardinal health that they have seen a spike in their infection rates in the or over the last two months.This case used a cardinal health eye pack sey2deydce that contained a level 3 surgical gown.The exact procedure event date was unknown by the customer.The procedure either was performed prior to the hold and recall notice(s) that were provided to customers beginning on 1/12/2020 or thereafter.No sample was available for evaluation and a work order/lot number was not provided for the kit, therefore, we are unable to confirm that the gown in the kit was part of the recall issued by cardinal health.
Additional Manufacturer Narrative
Supplemental mdr is being filed based on new information received from the customer following the submission of the initial mdr report submitted on 2/18/2020.Customer confirmed that they had filed the original complaint in error as there was no issue with the level 3 gowns, either gown 9545ncc or gown 90370nba, in the eye pack sey2deydce.

• Brand Name: EYE PACK (EYDCD)144
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 9722774
• Report Number: 1423537-2020-00416
• Device Sequence Number: 11495023
• Product Code: LRO
• UDI-Device Identifier: 10885425940974
• UDI-Public: 10885425940974
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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: SEY2DEYDCE
• Device Catalogue Number: SEY2DEYDCE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/17/2020
• 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