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

Model Number PN11NEXXE

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 304354854
• Report Number: 1423537-2022-00810
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 10195594483074
• UDI-Public: 10195594483074
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1