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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE NEURO INTERVENTIONAL PACK (NITAE)809 NEUROLOGICAL TRAY

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MEX03 MEXICO-JUAREZ PRESOURCE NEURO INTERVENTIONAL PACK (NITAE)809 NEUROLOGICAL TRAY Back to Search Results
Model Number SNE73NITA6
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2020
Event Type  malfunction  
Manufacturer Narrative
A review of the device history record for lot number 20200525-23-sh revealed the product was manufactured on may 31st 2020. Based on supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident. The average linting data is 0. 143g / 10pieces. No sample was returned for investigation, only photos were provided. No obvious abnormal lint was found on the surface of the product; however, there are neps on the surface of the towel. According to the supplier, or towel is made of cotton, so cotton fiber is born. The 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. C. Linting test method and acceptable criteria was stipulated to see the suction results. (
=
0. 38g/10pieces). In the folding process, supplier used one cloth pad under 100pieces semi-finished products to avoid linting stuck onto the products during product's transfer. The investigation revealed no abnormal situation happened in production; therefore, the root cause could not be determined. The complaint information was shared with the relevant sectors for their awareness. No action will be taken at this time, but the supplier will continue to monitor the trends for this type of incident.
 
Event Description
Customer reported excessive linting of blue cotton towel in the pack found during cerebral angiogram with intervention. There was no injury or adverse effect due to excessive lint.
 
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Brand NameNEURO INTERVENTIONAL PACK (NITAE)809
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
3651 birchwood dr.
waukegan, IL 60085
MDR Report Key10899856
MDR Text Key218907939
Report Number1423537-2020-00568
Device Sequence Number1
Product Code OJG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSNE73NITA6
Device Catalogue NumberSNE73NITA6
Device Lot Number474827
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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