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U.S. Department of Health and Human Services

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

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MEX03 MEXICO-JUAREZ PRESOURCE NEURO CRANI (CNQEC)308 NEUROLOGICAL TRAY Back to Search Results
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.
 
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Brand NameNEURO CRANI (CNQEC)308
Type of DeviceNEUROLOGICAL 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 Key10852003
MDR Text Key218170717
Report Number1423537-2020-00560
Device Sequence Number1
Product Code OJG
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 11/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSNE30CNQED
Device Catalogue NumberSNE30CNQED
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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