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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE SDMC CRANIOTOMY PACK (CNKSN)254 NEUROLOGICAL TRAY

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MEX03 MEXICO-JUAREZ PRESOURCE SDMC CRANIOTOMY PACK (CNKSN)254 NEUROLOGICAL TRAY Back to Search Results
Model Number SNE59CNKSO
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2020
Event Type  malfunction  
Manufacturer Narrative
Device history record could not be verified as lot number was not provided. There is no occurrence reported in the past 12 months. No sample was available for investigation. According to the supplier, the or towel is made of cotton, so lint is born and inevitable. The intended use of the or towel is used for applying medication or absorbing small amounts of body fluids from a patient's body surface. Supplier has worked with cardinal to better control the linting and has implemented several measures to improve it: the suction process was added before products' final folding and operators do it according to standard operation procedure requirements. Linting test method and acceptable criteria was stipulated to see the stipulated to see the suction results (
=
0. 38g/10 pieces). In the folding process, supplier used 1 cloth bag protect 100 pieces semi-finished products to avoid linting stuck onto the products during products' transfer. From the investigation, no abnormal situation happened in production and all linting test data for the past 12 months was within the acceptable range. Therefore, the root cause could not be determined. There is no action taken at this time, but supplier and cardinal will continue to monitor the trend of this type of incident.
 
Event Description
Pt reported that the blue towels or-1727bxg from the craniotomy pack sne59cnkso were linting and some of the lint got into the surgical field during a craniotomy. The towels were used to drape the mayo stand. Lint was found on the brain which was removed with irrigation and manual removal. No injury or adverse effect was reported. Patient demographics were not provided when requested. Report being filed for potential for injury.
 
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Brand NameSDMC CRANIOTOMY PACK (CNKSN)254
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 drive
waukegan, IL 60085
8478874151
MDR Report Key11174760
MDR Text Key226994049
Report Number1423537-2021-00587
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,user f
Reporter Occupation
Type of Report Initial
Report Date 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSNE59CNKSO
Device Catalogue NumberSNE59CNKSO
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2020
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

Patient Treatment Data
Date Received: 01/14/2021 Patient Sequence Number: 1
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