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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD® WHITACRE SPINAL NEEDLE 27 G X 4 11/16 IN.; ANESTHESIA CONDUCTION KIT
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CAREFUSION, INC BD® WHITACRE SPINAL NEEDLE 27 G X 4 11/16 IN.; ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405828
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/03/2023
Event Type  malfunction  
Event Description
It was reported while using bd® whitacre spinal needle 27 g x 4 11/16 in.The adaptor was damaged.There was no report of patient impact.The following information was provided by the initial reporter: the catheter to be disconnected.
 
Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd® whitacre spinal needle 27 g x 4 11/16 in.The adaptor was damaged.There was no report of patient impact.The following information was provided by the initial reporter: the catheter to be disconnected.
 
Manufacturer Narrative
Investigation summary no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.
 
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Brand Name
BD® WHITACRE SPINAL NEEDLE 27 G X 4 11/16 IN.
Type of Device
ANESTHESIA 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16248947
MDR Text Key308660485
Report Number1625685-2023-00008
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00382904058289
UDI-Public(01)00382904058289
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
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 02/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number405828
Device Catalogue Number405828
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/09/2023
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 Sequence Number1
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