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

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.

• Brand Name: BD¿ WHITACRE SPINAL TRAY
• Type of Device: ANESTHESIA 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 Key: 7480421
• MDR Text Key: 107143657
• Report Number: 2243072-2018-00214
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056513
• UDI-Public: 00382904056513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• 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 Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 405651
• Device Lot Number: B01L070D
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention