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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE RMC NEURO (BSDCG)195 NEUROLOGICAL TRAY

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MEX03 MEXICO-JUAREZ PRESOURCE RMC NEURO (BSDCG)195 NEUROLOGICAL TRAY Back to Search Results
Model Number SNE21BSDCH
Device Problem Material Frayed (1262)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2021
Event Type  Malfunction  
Manufacturer Narrative

Based on supplier investigation, a review of the device history record for lot number 191130958sh, revealed no exception was recorded that could lead to the reported incident. According to the supplier, workers perform the process operation in strict compliance with the standard operation procedure of gauze swab production. The actual complaint sample is not available at the time of investigation; therefore, the supplier was unable to determine the root cause. The supplier will continue to monitor trends for this type of incident.

 
Event Description

Customer reported the sponge gauze(c-nxr4416a) from neurological tray(sne21bsdch) was unraveling during lumbar disc procedure. The gauze sponge was used for removal and blotting of blood and fluids during the procedure. Reportedly, fraying from the gauze sponge was found on the patient and on scrub tech¿s hands. There was no injury, adverse effect or complications. No patient demographics were provided.

 
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Brand NameRMC NEURO (BSDCG)195
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 Key11729536
MDR Text Key247709553
Report Number1423537-2021-00626
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 04/26/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/26/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSNE21BSDCH
Device Catalogue NumberSNE21BSDCH
Device LOT Number484493
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/13/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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