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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE NEURO PACK (BSHNE)601 NEUROLOGICAL TRAY

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MEX03 MEXICO-JUAREZ PRESOURCE NEURO PACK (BSHNE)601 NEUROLOGICAL TRAY Back to Search Results
Model Number SNE37BSHNF
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2022
Event Type  malfunction  
Manufacturer Narrative
Based on supplier investigation, lot number 20210722-23-sh was reviewed. The device history record review did not indicate any exception that could lead to the reported incident. The average linting data is (b)(4). There was no sample available for investigation, but a photo was provided that showed some blue objects on the white gauze. According to supplier, operating room 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 as follows: suction machines have been installed in the grey cloth rolling process, dyeing process, and cutting process, the suction process was added before product's final folding, and workers process according to standard operation procedure requirement. Linting test method and acceptable criteria was stipulated to see the suction results. (b)(4) in the folding process, supplier used one cloth pad under 100pieces semi-finished products to avoid lint from being stuck onto the product during product's transfer. Based on the investigation, there were no abnormalities found during production of the or towels; 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, supplier will continue to monitor the trend of this type of incident.
 
Event Description
Customer has reported that they are experiencing linting from the operating room towels. Customer has indicated that the towels are leaving lint all over the gloves of the surgeon and on the technologists. The blue lint is also sticking to the patient when cleaning their skin at the conclusion of the case. There have been no injuries reported.
 
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Brand NameNEURO PACK (BSHNE)601
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
8478874151
MDR Report Key13860772
MDR Text Key287679547
Report Number1423537-2022-00741
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 Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSNE37BSHNF
Device Catalogue NumberSNE37BSHNF
Device Lot Number722955
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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