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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
Model Number 405828
Device Problems Complete Blockage (1094); Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2020
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. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that tray cse whit27g4. 7 we17g3. 5 swc x3795 catheter was clogged. The following information was provided by the initial reporter: material no: 405828 batch no: unknown (provided 0003177963) it was reported that the epidural catheter in the kit does not seem to be patent; unable to push meds through it. Event description per email states: epidural catheter in kit does not seem to be patent and i cannot push meds through it.
 
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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
MDR Report Key11067421
MDR Text Key242827582
Report Number1625685-2020-00101
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
SEE H.10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 05/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2021
Device Model Number405828
Device Catalogue Number405828
Device Lot Number0001377963
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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