MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Description: ineffective anesthesia, epidural placed.Event details: we experienced a total of 5 failed spinals (4 within the past week, the other 1 earlier in the month) and are questioning the efficacy of the included medications as that is the primary consistent factor during these events that occurred.We are still confirming the number of reports and verifying none of these have been duplicated, but this is the detail we have received so far.No specific patient harm was reported, although conversion to general anesthesia was required so the associated additional risks that go along with added procedure time, extended recovery, etc.Additional information: we do not know which tray was used for which case.We know of 4 cases in total (b)(6) 2025.One of the cases, the medication did not work at all; the other 3, it wore off rapidly.Two cases were anecdotally reported as about 20 minutes; the other case was not reported (the duration).Two moved to general anesthesia, one to an epidural and one was able to be managed with additional medication.At this point, a 5th case has not been confirmed.We have only the three trays we had previously reported.(b)(6) 2025 - resolved with additional medication.(b)(6) 2025 - epidural placed.(b)(6) 2025 - general anesthesia.
Additional Manufacturer Narrative
H11 -a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Material and lot number were not reported; however, a potential lot/material number was provided: mfr 405673, lots 0001611153 and 0001611047.Mfr 400866, lot 0001623325.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: multiple photos which display opened anesthesia trays and the glass ampoules for marcaine, lidocaine and bupivacaine were provided.Based on the images received, we were unable to confirm the reported concern of ineffective anesthesia.We conducted a thorough review of our internal manufacturing records and raw material history for the suspected lot numbers (0001611153 and 0001611047, tray 405673; and lot 0001623325, tray 400866).No quality issues or rejections related to this incident were identified, and all procedural and functional requirements for product release were 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.We appreciate you taking the time to bring this observation to our attention and regret any inconveniences this has caused.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: UNKNOWN ANESTHESIA TRAY
• 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: 22555641
• Report Number: 1625685-2025-00073
• Device Sequence Number: 15862512
• Product Code: CAZ
• UDI-Device Identifier: 50382904056730
• UDI-Public: (01)50382904056730
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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