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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION INC. SPINAL ANESTHESIA TRAY ANESTHESIA CONDUCTION KIT

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CAREFUSION INC. SPINAL ANESTHESIA TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 400866
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2020
Event Type  malfunction  
Event Description
Incident description: failed spinal - spinal did not fully set up after 20+ minutes. No complications noted with spinal, patient did report feeling some warmth in his legs and tingling in toes, but that is it. Converted to general anesthesia. The procedure was carried out with no complications. Marcaine: mfr: hospira, ndc: 0409-1761-18, lot#: 950953a, expiration date: 11/01/2021. Lidocaine: mfr: hospira, lot#: an1171, expiration date: 01/01/2022.
 
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Brand NameSPINAL ANESTHESIA TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION INC.
75 north fairway drive
vernon hills IL 60061
MDR Report Key10747798
MDR Text Key213465305
Report Number10747798
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 10/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number400866
Device Catalogue Number400866
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/20/2020
Event Location Hospital
Date Report to Manufacturer10/28/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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