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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 BLUE DRAPE ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405672
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/17/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter occupation: demand planner, logistics supply chain operations. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 0001346903. Medical device expiration date: 2021-10-31. Device manufacture date: 2020-02-28. Medical device lot #: 0001346885. Medical device expiration date: 2021-10-31. Device manufacture date: 2020-02-28. Pma/510(k)#: enforcement discretion. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that an unspecified number of tray spn whit25g3. 5 l/b-d/e blue drape experienced ineffective anesthesia -failed to work. Product defect occurred during use. The following information was provided by the initial reporter: material no: 405672 ; batch no: 0001346903 , 0001346885. I have just been informed from one of our facilities that the bupivacaine in our bd anesthesia tray (part number 405672) does not work for numbing a patient. They tried 2 trays and neither worked. The lot numbers are 0001346903 (0 kits in the isc, but we will be receiving some back from the facility) and 001346885 (currently 104 kits on hand in the isc).
 
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Brand NameTRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key10377102
MDR Text Key204736955
Report Number1625685-2020-00071
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number405672
Device Catalogue Number405672
Device Lot NumberSEE H10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2020
Was Device Evaluated by Manufacturer? Yes
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: 08/06/2020 Patient Sequence Number: 1
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