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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ SPINAL TRAY ANESTHESIA CONDUCTION KIT

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BECTON DICKINSON UNSPECIFIED BD¿ SPINAL TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number UNKNOWN
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Awareness during Anaesthesia (1707)
Event Date 08/13/2020
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and 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)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Date of event: unknown. The date received by manufacturer has been used for this field. 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 the unspecified bd¿ spinal tray was ineffective during use on the patient. This complaint was created to capture the 2nd of 5 related incidents. The following information was provided by the initial reporter: by failure we mean while placing the spinal everything seemed perfect but the spinal did not take effect properly. Doctor's spinal set in but then wore off very quickly. In my two one patient had good analgesia and were able to complete the surgery but they could still move their surgical leg. In another one dermatome wasn't numb but the rest of the abdomen was for a c-section. I also had another patient with a low spinal level where i had so supplement with ketamine. Another doctor also had 2 failures but i don't know the details. I think there is something wrong with the hyperbaric bupivacaine included in the kit. Its like the medication is not the correct potency so the patients are getting under dosed.
 
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Brand NameUNSPECIFIED BD¿ SPINAL TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key10489658
MDR Text Key207178156
Report Number2243072-2020-01361
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 10/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2020
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 Treatment Data
Date Received: 09/03/2020 Patient Sequence Number: 1
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