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U.S. Department of Health and Human Services

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

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BECTON DICKINSON BD¿ WHITACRE SPINAL TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 405651
Device Problem Device Inoperable (1663)
Patient Problem Pain (1994)
Event Date 04/08/2018
Event Type  Injury  
Manufacturer Narrative
The manufacturing location for this product is (b)(4). This site is not registered with the fda. 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. 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 while performing a procedure with a bd¿ whitacre spinal tray with the use of lidocaine as the anesthesia medication, the medication was found to be ineffective. As a result, when the patient was pinch tested at the incision site, the patient "started bucking. " the patient was placed under general anesthesia for the remainder of the procedure.
 
Manufacturer Narrative
Over a period of more than 10 years, no test result from samples returned due to ineffective anesthesia has ever failed to meet specifications. The causes of ineffective anesthesia have been well documented in clinical literature for many years. Whereas a strong history of testing has supported that drug potency is not the cause, the actual cause may not always be ascertained. Bd has a long history of test results to support that drug potency issues have not been the cause of ineffective anesthesia events reported to bd through the complaint system. As a preventive action, the vendor of the applicable drug component (hospira/pfizer) will be notified of the reported failure mode from the customer. Likewise, the complaint will be entered into the complaint management system and will be tracked & trended for future occurrences and reviewed/investigated through the quality data analysis (qda) process if an adverse trend is identified. A device history review performed by hospira/pfizer shows that the reported lot met all specifications. Root cause is undetermined.
 
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Brand NameBD¿ WHITACRE SPINAL TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7480421
MDR Text Key107143657
Report Number2243072-2018-00214
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2018
Device Catalogue Number405651
Device Lot NumberB01L070D
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2017
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: 05/02/2018 Patient Sequence Number: 1
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