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

Catalog Number 405671

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Pma/510(k): enforcement discretion.Investigation: bd was unable to perform a thorough investigation as no sample, lot/batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch/lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.The root cause is undetermined.

Event Description

It was reported that when using the bd¿ whitacre spinal tray the patient does not get adequately numb, resulting in either changing the medicating being used or induction of another anesthesia technique.There was no report of exposure, injury or medical interventions but the plan of care does change and is possibly delayed when this happens.

• Brand Name: BD¿ WHITACRE SPINAL TRAY
• Type of Device: ANESTHESIA SPINAL NEEDLE
• 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: 7060125
• MDR Text Key: 92956987
• Report Number: 2243072-2017-00268
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 00382904056711
• UDI-Public: 00382904056711
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/03/2017

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
• Device Operator: Other
• Device Catalogue Number: 405671
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/27/2017
• 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 Number: 1
• Patient Outcome(s): Other