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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.
 
Manufacturer Narrative
Bd was initially made aware of this complaint on 2019-04-30.At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident.Additional information was later received on 2019-06-04 that changed the reportability determination, thus why the date was used at the date received by manufacturer in the initial mdr.However, further review dictates that the initial awareness date should have been provided in the mdr, and so the following fields have been corrected: date of event: unknown.The date received by manufacturer has been used for this field.Date of event: (b)(6) 2019 date received by manufacturer: 2019-04-30.
 
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 Name
TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key8711895
MDR Text Key148804014
Report Number1625685-2019-00052
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00382904058289
UDI-Public00382904058289
Combination Product (y/n)N
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
Report Date 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number405828
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 06/04/2019
Initial Date FDA Received06/19/2019
Supplement Dates Manufacturer Received04/30/2019
Supplement Dates FDA Received07/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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