MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE PODIATRY PACK (PYPTA)269; GENERAL SURGERY TRAY (KIT)

Model Number	SOP54PYPTA
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/1980
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the supplier investigation, a review of the device history record could not be conducted as lot number was not provided.A sample was not provided for investigation, but a review by the supplier of their records for the past 12 months did not identify any similar defects.The raw materials used for the manufacturing of this gown have not changed according to the supplier.Therefore; based on the information available for this investigation, the root cause could not be determined.All involved personnel have been informed of this reported issue and the supplier will continue to monitor.
Event or Problem Description
Customer informed cardinal that they are tracking a patient with an infection from a case that occurred on (b)(6) 2019.This case used a cardinal health podiatry pack that contained a level 3 surgical gown.The procedure was performed prior to the hold and recall notice(s) that were provided to customers beginning on (b)(6) 2020.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.

• Brand Name: PODIATRY PACK (PYPTA)269
• 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: 9696262
• Report Number: 1423537-2020-00412
• Device Sequence Number: 2449538
• Product Code: LRO
• UDI-Device Identifier: 10887488375717
• UDI-Public: 10887488375717
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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: SOP54PYPTA
• Device Catalogue Number: SOP54PYPTA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/11/2020
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 83