MAUDE Adverse Event Report: BECTON DICKINSON TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE; ANESTHESIA CONDUCTION KIT

Catalog Number 405672

Device Problem Lack of Effect (4065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

Material #405672.Lot #unknown.It was reported by customer that spinal anesthesia tray did not properly numb the patient on three separate occasions from the same lot.Additional information: could you please provide a further description of the issue? the anesthesiologist was able to administer the spinal anesthesia.The patient responded as expected to the anesthesia with decreased bp, however, the spinal did not set up to numb her sensory for the procedure.She was unable to move her legs, but could still feel everything.This happened with at least 5 of the spinal trays with the same lot #.2.Can you please provide the lot number associated with reported issue? (b)(6), can you provide this information? 3.Can you please provide a exact date of event? 2/9/2024.What was the impact to the patient? was there any injury? if so, please describe and include any medical treatment needed as a result? patient required general anesthesia after the spinal anesthesia didn¿t provide adequate coverage.

Manufacturer Narrative

One empty tray and two assembled trays were returned.No defects or issues observed.A device history review was performed for lot 0001525982 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples from the same lot were evaluated, no issues or defects observed.The sterilization release record was reviewed for the finished good trays, the requirements for it's release were met.Based on the investigation results, no manufacturing related defects could be identified and therefore, a cause for the reported incident could not be determined.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Manufacturing personnel have been notified of this incident to increase awareness.

Event Description

Additional information: 5.How was the issue resolved? all spinal trays with the affected lot number were pulled from our ors and given to our facility materials management team 6.Is there a photo or sample available showing the reported issue? if yes, are you able to provide the address of the facility for us to ship the return label? steve may be able to provide this image.Lot numbers are: 0001525982 plus one with only the front.I have 3 samples that can be sent back.Our address is: (b)(6).

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18874503
• MDR Text Key: 337318100
• Report Number: 1625685-2024-00026
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056728
• UDI-Public: (01)00382904056728
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405672
• Device Lot Number: 0001525982
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention