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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405673
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/13/2020
Event Type  malfunction  
Manufacturer Narrative
Suspect product name and strength: bupivacaine hcl (0. 75%) with dextrose (8. 25%), 2 ml (marcaine) medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. Fda device problem code: 2682. Fda patient problem code: 1707.
 
Event Description
It was reported that 4 trays spn whit25g3. 5 l/b-d/e had ineffective anesthesia during use. The following information was provided by the initial reporter: by failure we mean while placing the spinal everything seemed perfect but the spinal did not take effect properly. Dr. Spinal set in but then wore off very quickly. In my two one patient had good analgesia and were able to complete the surgery but they could still move their surgical leg. In another one dermatome wasn't numb but the rest of the abdomen was for a c-section. I also had another patient with a low spinal level where i had so supplement with ketamine. Dr. Also had 2 failures but i don't know the details. I think there is something wrong with the hyperbaric bupivacaine included in the kit. Its like the medication is not the correct potency so the patients are getting under dosed.
 
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Brand NameTRAY SPN WHIT25G3.5 L/B-D/E
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key10487969
MDR Text Key206820020
Report Number1625685-2020-00081
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)Y
PMA/PMN Number
DISCRETION
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup,Followup
Report Date 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number405673
Device Catalogue Number405673
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/03/2020 Patient Sequence Number: 1
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