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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE NEURO PACK (SSMSL)167 NEUROLOGICAL TRAY

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MEX03 MEXICO-JUAREZ PRESOURCE NEURO PACK (SSMSL)167 NEUROLOGICAL TRAY Back to Search Results
Model Number SNE22SSMS9
Device Problem Material Frayed (1262)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2021
Event Type  Malfunction  
Manufacturer Narrative

Based on supplier investigation, the device history record(dhr) review did not indicate any exception that could lead to the reported incident. The device history record for the lot number reported, 20200922-23-sh, revealed the product was finished on december 13th, 2020. The average linting data is 0. 184g/10pcs. The sample was not returned at the time of this investigation, only a photo was provided. A review of the photo revealed blue lint was found on doctor's hands. 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: 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. 38g/10pieces). D. 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. 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 blue towels (pwtb04-stm) that come inside the neuro pack (sne22ssms9) are reportedly releasing a great amount of lint. Dr. (b)(6) called the clinical manager into room 12 to show her lint on his hands. No injury reported, but dr. (b)(6) mentioned this has occurred before and he is worried about the lint getting into the surgical wound and the sterile field.

 
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Brand NameNEURO PACK (SSMSL)167
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 Key12163500
MDR Text Key261770872
Report Number1423537-2021-00652
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 07/13/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/13/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSNE22SSMS9
Device Catalogue NumberSNE22SSMS9
Device LOT Number623937
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/05/2021
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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