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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
Catalog Number 405675
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/18/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Pma / 510(k) #: enforcement discretion. 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 the packaged bd whitacre spinal trays had different items in the trays and were missing two drugs. There was no report of exposure, injury, or medical intervention noted.
 
Event Description
It was reported that the packaged bd whitacre spinal trays had different items in the trays and were missing two drugs. There was no report of exposure, injury, or medical intervention noted.
 
Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields. This supplemental emdr is filed to provide the following omitted fields: event attributed to: other. Device single use?: no. Device returned to manufacture: yes. 2 cases (20 units) of lot 0001233692 were returned for sample evaluation. All units were visually inspected per the requirements of the bill of materials for product code (b)(4). The inspection did not identify any discrepancies with the components included in the 20 units. A review of the device history record (dhr) shows that all inspection results passed per the dhr process and no anomalies were noticed during production. The review also noted that lot 0001233692 was manufactured per a project without the bupivacaine and marcaine drug components due to supply chain disruptions with the vendor. As noted above, the investigation did note the bupivacaine and marcaine components were not included based on the manufacturing deviation per a project. Consequently, the reported defect was not confirmed per the sample analysis. No probable contributors were identified from any of the noted factors above. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends.
 
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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
MDR Report Key7759834
MDR Text Key116622710
Report Number1625685-2018-00030
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 distributor,other
Type of Report Initial,Followup
Report Date 09/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2020
Device Catalogue Number405675
Device Lot Number0001233692
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/07/2018 Patient Sequence Number: 1
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