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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX SPINAL SINGLE SHOT TRAYS ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC. PORTEX SPINAL SINGLE SHOT TRAYS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number NEPI-NLD-15597-20
Device Problem Infusion or Flow Problem (2964)
Patient Problem Therapeutic Response, Decreased (2271)
Event Type  malfunction  
Event Description
It was reported that bupivacane in the tray was weak. No patient injury or complications were reported in relation to this event.
 
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Brand NamePORTEX SPINAL SINGLE SHOT TRAYS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene NH 03431
MDR Report Key11315808
MDR Text Key231441146
Report Number3012307300-2021-01175
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 04/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2021
Device Catalogue NumberNEPI-NLD-15597-20
Device Lot Number4052153
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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