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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE KIT, CRANI (RLCU )470 NEUROLOGICAL TRAY

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MEX03 MEXICO-JUAREZ PRESOURCE KIT, CRANI (RLCU )470 NEUROLOGICAL TRAY Back to Search Results
Model Number PNVXCRLC5
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2021
Event Type  malfunction  
Manufacturer Narrative
From the device history record, lot# 20201119-23-sh was finished on 12th dec 2020. No exception was recorded in the device history record that could lead to the reported incident. The average linting data is 0. 15g/10pcs. No sample returned for investigation. According to the supplier, the operating room towel is made of cotton, so cotton fiber is born. 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. (b)(4). 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 or dhr. 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, but supplier will continue to monitor the trend of this type of incident.
 
Event Description
Customer reported blue cotton operating room towels pwtb04-stm from the craniotomy pack pnvxcrlc5 are linting causing concerns for surgical site infections. There was no adverse effect to the patient. The scrub and doctors noticed the lint on the instruments, especially when they were working under the microscope. No other information was provided when requested.
 
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Brand NameKIT, CRANI (RLCU )470
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 Key12112188
MDR Text Key261914926
Report Number1423537-2021-00646
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 Other Health Care Professional
Type of Report Initial
Report Date 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPNVXCRLC5
Device Catalogue NumberPNVXCRLC5
Device Lot Number611490
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 Answer Provided
Date Device Manufactured04/15/2021
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/02/2021 Patient Sequence Number: 1
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