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

Catalog Number	405651
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/08/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.

• Brand Name: BD¿ WHITACRE SPINAL TRAY
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7480421
• Report Number: 2243072-2018-00214
• Device Sequence Number: 13536517
• Product Code: CAZ
• UDI-Device Identifier: 00382904056513
• UDI-Public: 00382904056513
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 405651
• Device Lot Number: B01L070D
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention