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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN QNKE26G3.5 L/B-D ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC TRAY SPN QNKE26G3.5 L/B-D ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 405632
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Information (3190)
Event Date 02/26/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Pma / 510(k)#: enforcement discretion. Device manufacture date: unknown. Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. A device history review could not be completed as no batch number was provided. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Investigation conclusion: based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
 
Event Description
It was reported that the tray spn qnke26g3. 5 l/b-d was noticed to have incorrect content within it before use, as it did not contain "bupivacaine". As reported by the customer, "per customer, reported the pack had the wrong contents in the pack. The pack they received did not contain bupivacaine. ".
 
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Brand NameTRAY SPN QNKE26G3.5 L/B-D
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer (Section G)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8425372
MDR Text Key139076970
Report Number1625685-2019-00017
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
SEE H.10.
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number405632
Device Lot NumberUNKNOWN
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 Received02/26/2019
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: 03/15/2019 Patient Sequence Number: 1
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