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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TX134 TX-EL PASO-DON HASKINS KIT, NEURO (JEGI )679 NEUROLOGICAL TRAY

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TX134 TX-EL PASO-DON HASKINS KIT, NEURO (JEGI )679 NEUROLOGICAL TRAY Back to Search Results
Model Number PN21NJEGJ
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/16/2020
Event Type  malfunction  
Manufacturer Narrative
No sample was returned for investigation. The supplier stated they could not review the device history record during their investigation because the lot number was not provided. However, supplier reviewed their records for the last 2 years and did not find anything abnormal. 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. Linting test method and acceptable criteria was stipulated to see the suction results. (
=
0. 38 g/10 pieces). 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 happened in production; therefore, the root cause could not be determined. The complaint information was shared with the relevant sectors for their awareness. There is no action taken at this time, but the supplier will continue to monitor trends for this type of incident.
 
Event Description
Customer reported linting was discovered while the surgeon was drying his hands after scrubbing for a neurosurgery. No injury or delay noted. The sample was discarded.
 
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Brand NameKIT, NEURO (JEGI )679
Type of DeviceNEUROLOGICAL TRAY
Manufacturer (Section D)
TX134 TX-EL PASO-DON HASKINS
1320 don haskins
el paso TX 79936
Manufacturer (Section G)
TX134 TX-EL PASO-DON HASKINS
1320 don haskins
el paso TX 79936
Manufacturer Contact
patricia tucker
3651 birchwood drive
waukegan, IL 60085
8478874151
MDR Report Key10399263
MDR Text Key204363318
Report Number1423537-2020-00497
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 08/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPN21NJEGJ
Device Catalogue NumberPN21NJEGJ
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 Received07/16/2020
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

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