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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD WHITACRE¿ SPINAL TRAY ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC BD WHITACRE¿ SPINAL TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405699
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that a black particle of foreign matter was found in the bd whitacre¿ spinal tray syringe. The following information was provided by the initial reporter: "the customer reported that on (b)(6) 2021, the anesthesiologist is giving spinal anesthesia to a patient, when he prepares the syringe with the anesthetic medicine of bupivacaine, is going to administer it, observes that the syringe has a colored black particle visible with movement, he speculates that it might be from the plunger of the syringe. ".
 
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Brand NameBD WHITACRE¿ SPINAL TRAY
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13004331
MDR Text Key283612587
Report Number1625685-2021-00101
Device Sequence Number1
Product Code CAZ
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Model Number405699
Device Catalogue Number405699
Device Lot Number0001420447
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2021
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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