MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE NEURO CRANI (CNQEC)308; NEUROLOGICAL TRAY

Model Number SNE30CNQED

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Based on supplier investigation, the device history record could not be reviewed as a lot number was not provided.Supplier reviewed records over the last 2 years and no abnormal situation was found.There are 182 occurrences reported in the past 12 months.No sample was available for investigation, but a photo was provided.The photo showed lint on the hands of the staff member.According to the supplier, the or towel is made of cotton, so cotton fiber is born.Supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.Linting test method and acceptable criteria was stipulated to see the suction results.(b)(4).In the folding process, supplier used one cloth pad under (b)(4) semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, there is no abnormal situation that has occurred in production.Therefore, 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 a large amount of lint on the blue towels pwtb04-stm from the neuro craniotomy kit sne30cnqed.No injury was reported.No clinical data or patient demographics (height, weight, age, sex) were provided after numerous attempts to obtain.

• Brand Name: NEURO CRANI (CNQEC)308
• 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: 10852003
• MDR Text Key: 218170717
• Report Number: 1423537-2020-00560
• Device Sequence Number: 1
• Product Code: OJG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/17/2020

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: SNE30CNQED
• Device Catalogue Number: SNE30CNQED
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1