MAUDE Adverse Event Report: CARDINAL HEALTH 200. LLC KIT, NEURO SJMC (EXXD )887; NEUROLOGICAL TRAY

Model Number	PN11NEXXE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
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 reported fibers from the gauze kc7317ap in the neuro kit pn11nexxe came loose and were found within the patient via the surgical incision site.There was no injury reported.No further information was provided when requested.
Additional Manufacturer Narrative
Supplemental report is being filed since the results of investigation are available.Device history record (dhr) of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.The sample was not returned for investigation; therefore, an evaluation of the complaint product for deficiency of construction could not be performed and the root cause remains unknown.Without a specific assignable rot cause, no specific corrective actions can be completed; however, we will continue to monitor this failure mode for this product.

• Brand Name: KIT, NEURO SJMC (EXXD )887
• Common Device Name: NEUROLOGICAL TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200. LLC; 3651 birchwood dr; waukegan IL 60085
• 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: 15087926
• Report Number: 1423537-2022-00810
• Device Sequence Number: 12052261
• Product Code: OJG
• UDI-Device Identifier: 10195594483074
• UDI-Public: 10195594483074
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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
• Operator of Device: Health Professional
• Device Model Number: PN11NEXXE
• Device Catalogue Number: PN11NEXXE
• Device Lot Number: 768612
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown