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

Catalog Number 405671

Device Problem Lack of Effect (4065)

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

Event Date 02/07/2024

Event Type  Injury  

Event Description

Materials#: 405671.Batch#: 0001537529.It was reported by the customer that issue with the bupivacaine medication in our spinal trays not working.Verbatim: issue with the bupivacaine medication in our spinal trays not working.1.Are you able to provide the dates of the events in the format of mm-dd-yyyy? unknown.2.How was the patient outcome? are there any clinical signs, health consequences or impact? patient went under anesthesia and is fine per the or staff.

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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.

Manufacturer Narrative

Four samples received for investigation.No defects or issues observed.A device history review was performed for lot 0001537529 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: 1.Are you able to provide the dates of the events in the format of mm-dd-yyyy? unknown.2.How was the patient outcome? are there any clinical signs, health consequences or impact? patient went under anesthesia and is fine per the or staff.

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E PLAST 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: 18676168
• MDR Text Key: 336078133
• Report Number: 1625685-2024-00015
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: (01)00382904056711
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405671
• Device Lot Number: 0001537529
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention