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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE ARNOT NEURO PACK 191 NEUROLOGICAL TRAY

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MEX03 MEXICO-JUAREZ PRESOURCE ARNOT NEURO PACK 191 NEUROLOGICAL TRAY Back to Search Results
Model Number SNE7AANAOA
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/25/2020
Event Type  Malfunction  
Manufacturer Narrative

From the device history record, lot#190725591sh, showed no exception recorded in the device history record that could lead to the reported incident. Based on supplier investigation, device history record review did not indicate any exception that could lead to the reported incident. The production process of bleaching, drying cutting, folding, steam pretreatment, counting, banding and packaging was performed according to standard operation procedure requirements. As sample was not available for investigation, 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 the supplier will continue to monitor the trend of this type of incident.

 
Event Description

Customer reported that the interwoven threads from xray gauze sponge c-nxr4416a from the arnot neuro pack sne7aanaoa are coming apart and were found on the surgical instruments during a back surgery. The sterile field was replaced and a count of supplies performed requiring minimal delay of minutes per customer. There was no injury or adverse effect to the patient. Based on potential risk to the patient, cardinal health is proactively filing an mdr.

 
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Brand NameARNOT NEURO PACK 191
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
1500 waukegan rd
waukegan, IL 60085
8478874151
MDR Report Key9873813
MDR Text Key202715807
Report Number1423537-2020-00442
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 FACI
Reporter Occupation
Type of Report Initial
Report Date 03/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSNE7AANAOA
Device Catalogue NumberSNE7AANAOA
Device LOT Number308060
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/09/2019
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: 03/24/2020 Patient Sequence Number: 1
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