MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE ARNOT NEURO PACK 191; NEUROLOGICAL TRAY

Model Number SNE7AANAOA

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

From the device history record, lot#190725591sh, showed no exception recorded in the device history record that could lead to the reported incident.Based on supplier investigation, device history record review did not indicate any exception that could lead to the reported incident.The production process of bleaching, drying cutting, folding, steam pretreatment, counting, banding and packaging was performed according to standard operation procedure requirements.As sample was not available for investigation, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but the supplier will continue to monitor the trend of this type of incident.

Event Description

Customer reported that the interwoven threads from xray gauze sponge c-nxr4416a from the arnot neuro pack sne7aanaoa are coming apart and were found on the surgical instruments during a back surgery.The sterile field was replaced and a count of supplies performed requiring minimal delay of minutes per customer.There was no injury or adverse effect to the patient.Based on potential risk to the patient, cardinal health is proactively filing an mdr.

• Brand Name: ARNOT NEURO PACK 191
• Type of Device: NEUROLOGICAL TRAY
• 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 ; 1500 waukegan rd; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 9873813
• MDR Text Key: 202715807
• Report Number: 1423537-2020-00442
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 10888439407297
• UDI-Public: 10888439407297
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SNE7AANAOA
• Device Catalogue Number: SNE7AANAOA
• Device Lot Number: 308060
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/24/2020
• Date Device Manufactured: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other