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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE BASIC NEURO PACK (BNGHB)838 NEUROLOGICAL TRAY

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MEX03 MEXICO-JUAREZ PRESOURCE BASIC NEURO PACK (BNGHB)838 NEUROLOGICAL TRAY Back to Search Results
Model Number SNE18BNGHB
Device Problem Material Frayed (1262)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2020
Event Type  Malfunction  
Manufacturer Narrative

A review of the device history record for the lot number reported, lot# 20200711-23-sh, revealed the product was manufactured on august 14th, 2020. Based on the supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident. The average linting data is (b)(4). No sample was available at the time of this investigation. 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. (b)(4). 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. The investigation revealed no abnormal situation happened during 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 the trend for this type of incident.

 
Event Description

Customer reported linting of blue towels, pwtb04-stm, from the basic neuro pack while opening and draping for a neuro case. Reportedly, lint was flying around sterile field. Patient demographics not provided upon request. There was no injury reported and patient is reported as good.

 
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Brand NameBASIC NEURO PACK (BNGHB)838
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 Key11142770
MDR Text Key226007229
Report Number1423537-2021-00585
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 01/08/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/08/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSNE18BNGHB
Device Catalogue NumberSNE18BNGHB
Device LOT Number509920
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/02/2020
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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