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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD TRAY SPN SPT24G3.5 B/L/E ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC BD TRAY SPN SPT24G3.5 B/L/E ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405707
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/09/2020
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 anesthesia was ineffective with a bd tray spn spt24g3. 5 b/l/e. This occurred on 5 separate occasions during use, however, the patient information is unknown. The following information was provided by the initial reporter: it was reported that 5 trays had ineffective medication. Additionally, on (b)(6) 2020 the bd sales consultant provided the following additional information: did all 5 incidents occur on the same day? yes. Are you able to provide patient identifiers? apart from they all occurred in our labor and delivery floor, i can not. Was there serious injury? as far as i have heard, no. Were there erroneous results? yes, the medication bupivacaine was ineffective when administered. Did the course of treatment change? yes, the anesthesiologists had to supply bupivacaine from our own pyxis station. Was there exposure to blood/bodily fluid? as far as i have heard, no. Were there any other actions taken? we notified our supplier to get a different lot number case sent (we have yet to hear back) will samples be returning for investigation? i assume you mean a sample tray, in which case yes. I would also like to get the 3 unopened cases (30 trays) we have replaced since we have to wait for this investigation; we don't really trust this lot number anymore for continuing patient care.
 
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Brand NameBD TRAY SPN SPT24G3.5 B/L/E
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key10015601
MDR Text Key201873534
Report Number1625685-2020-00044
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 health professional,other,use
Type of Report Initial,Followup
Report Date 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model Number405707
Device Catalogue Number405707
Device Lot Number0001329882
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/30/2020 Patient Sequence Number: 1
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