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

Model Number SBA73BRAMA

Device Problem Nonstandard Device (1420)

Patient Problem Bacterial Infection (1735)

Event Date 10/19/2019

Event Type  Injury  

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 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
• Type of Device: 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
• Manufacturer (Section G): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 9759097
• MDR Text Key: 192651063
• Report Number: 1423537-2020-00427
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10885425387274
• UDI-Public: 10885425387274
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SBA73BRAMA
• Device Catalogue Number: SBA73BRAMA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2020
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other