• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CRANIOTOMY PACK (CNKDC)692 NEUROLOGICAL TRAY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEX03 MEXICO-JUAREZ PRESOURCE CRANIOTOMY PACK (CNKDC)692 NEUROLOGICAL TRAY Back to Search Results
Model Number SNE69CNKDD
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2020
Event Type  malfunction  
Manufacturer Narrative
Based on the supplier¿s investigation, device history record could not be reviewed because the lot number was not provided. However, the supplier reviewed the records in the last two years and no abnormal situation was found. No sample was available at the time of the investigation. According to 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: a. Suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process. B. 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. 38 g/10 pieces). D. In the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer. From the investigation, no abnormal situation occurred during production and the sample was not available; therefore, the root cause could not be determined. The complaint information was shared with the relevant sectors for their awareness. No action taken at this time, but the supplier will continue to monitor trends for this type of incident.
 
Event Description
Customer reports too much lint coming off of the towels.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCRANIOTOMY PACK (CNKDC)692
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 Key10299197
MDR Text Key200453036
Report Number1423537-2020-00486
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 07/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSNE69CNKDD
Device Catalogue NumberSNE69CNKDD
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-