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

Model Number	SBA73BRAMA
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	10/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this investigation no sample or lot number were provided.Many attempts were made to retrieve investigation results from the supplier, holymed (b)(4), however we have learned they have de-listed their fda registration and they are no longer in business since january 2020.As such, we do not expect to receive any feedback or investigation results from the supplier.Cardinal health is no longer doing business with this supplier.Cardinal health has initiated a formal recall (event #: 2020-02735) to the fda of certain cardinal health convenience kits that contained the gowns manufactured by the supplier holymed siyang.
Event or Problem Description
Based on information received from the customer allegedly a patient had an infection, on (b)(6) 2019.The infection was called non-tb atypical microbacteria.Reportedly the health department came in and did a thorough testing and found nothing.The customer provided no further information after several attempts.

• Brand Name: GENERAL BREAST PACK
• 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: 9759097
• Report Number: 1423537-2020-00427
• Device Sequence Number: 19495713
• Product Code: LRO
• UDI-Device Identifier: 10885425387274
• UDI-Public: 10885425387274
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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: SBA73BRAMA
• Device Catalogue Number: SBA73BRAMA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2020
• Initial Report FDA Received Date: 02/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other