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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795 ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795 ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 405828
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/30/2019
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. 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. A device history review could not be completed as no batch number was provided. Investigation conclusion: based on no sample, the investigation concluded, bd was not able to verify the indicated failure. Root cause description: no root cause can be determined as no samples were received. Rationale: 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.
 
Event Description
It was reported that the tray cse whit27g4. 7 we17g3. 5 swc x3795 blunt fill needle was found on top of the wrapping before use, presenting a sterility issue. The following information was provided by the initial reporter: "inconsistent blunt fill needle on top of wrapping''. Stated that the needle was on top of the wrapping but should be under / wrapped in the wrapping. The sales rep noted that this does cause a sterility issue when opening the tray.
 
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Brand NameTRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795
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 Key8711895
MDR Text Key148804014
Report Number1625685-2019-00052
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
DISCRETION
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number405828
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2019
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: 06/19/2019 Patient Sequence Number: 1
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