Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANESTHESIA TRAY PROCEDURE SPINAL; ANESTHESIA CONDUCTION KIT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ANESTHESIA TRAY PROCEDURE SPINAL; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 401385
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Awareness during Anaesthesia (1707)
Event Date 11/05/2020
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(6) has been listed and the (b)(6) fda registration number has been used for the manufacture report number.The reported lot # [960803a] was not found for the reported catalog # [401385].Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that the anesthesia in 2 anesthesia tray procedure spinal kits was ineffective during use.The following information was provided by the initial reporter: "2 failed spinal in the row ( cerclage and section) due to bupi vial from the kit".
 
Event Description
It was reported that the anesthesia in 2 anesthesia tray procedure spinal kits was ineffective during use.The following information was provided by the initial reporter: "2 failed spinal in the row ( cerclage and section) due to bupi vial from the kit".
 
Manufacturer Narrative
H6: investigation summary there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and but no records of lot 960803a were found for the reported device.Therefore, a review could not determine if there were any manufacturing related issues found during production.H3 other text : see h10.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ANESTHESIA TRAY PROCEDURE SPINAL
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key10939355
MDR Text Key219342168
Report Number2243072-2020-01988
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number401385
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/13/2021
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
-
-