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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE NEURO PACK (NPNTC)212 GENERAL SURGERY TRAY (KIT)

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MEX03 MEXICO-JUAREZ PRESOURCE NEURO PACK (NPNTC)212 GENERAL SURGERY TRAY (KIT) Back to Search Results
Model Number SNE69NPNTD
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2020
Event Type  Malfunction  
Manufacturer Narrative

From the device history record (dhr), lot number 20200526-23-sh was finished on 06/04/2020. No exception was recorded in the device history record that could lead to the reported incident. The average linting data is 0. 149g/10 pieces. No sample was returned for the investigation. From the investigation, there is no abnormal situation which happened during production in the device history record. 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, however, we will continue to monitor the trend of this type of incident. According to supplier, or towel is made of cotton, so cotton fiber is born. Supplier 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. 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.

 
Event Description

Based on information received from the customer they stated the or cotton towel is reportedly being fuzzy. The procedure was laminectomy, there was no injury and no delay in the procedure.

 
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Brand NameNEURO PACK (NPNTC)212
Type of DeviceGENERAL SURGERY TRAY (KIT)
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 Key10691148
MDR Text Key213626038
Report Number1423537-2020-00544
Device Sequence Number1
Product Code LRO
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 10/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSNE69NPNTD
Device Catalogue NumberSNE69NPNTD
Device LOT Number468804
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/13/2020
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/16/2020 Patient Sequence Number: 1
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