MAUDE Adverse Event Report: BECTON DICKINSON NOT APPLICABLE; ANESTHESIA CONDUCTION KIT

Catalog Number	400866
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported patient did not have adequate numbing and felt discomfort during the surgery.Event description: the tray they used was ref 400866 lot 0001622776.There was an incident when this tray was used for spinal anesthesia prior to a cesarean delivery, and the patient did not have adequate numbing and felt discomfort during the surgery.Sedation was necessary for the surgery, and the patient experienced 10 out of 10 pain immediately following the procedure, and required use of a pca pump.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Additional Manufacturer Narrative
(b)(4).Follow up no photos or physical samples that display the reported condition were available for investigation.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001622776 was performed and no recorded quality problems or rejections related to this incident were found, all procedural and functional requirements for product release have been met.We reviewed our sterilization records, no issues were identified during the sterilization process.The certification of analysis, provided to bd by the supplier has been reviewed for the reported lot, all testing done by the supplier verifies the product passed required inspections and is authorized for use.Based on the available information, we were unable to identify a root cause within our process that could impact the efficacy of the medication included in our kits.As the medication is supplied by an external partner, we have notified them of this incident.

• Brand Name: NOT APPLICABLE
• Common Device Name: 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: 22963527
• Report Number: 1625685-2025-00084
• Device Sequence Number: 8260371
• Product Code: CAZ
• UDI-Device Identifier: 50382904008661
• UDI-Public: (01)50382904008661(17)260131(10)0001622776
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 400866
• Device Lot Number: 0001622776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown