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	06/23/2025
Type of Reportable Event	Serious Injury
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 (b)(4) lots: 0001611153 and 0001611047, mfr (b)(4) lot: 0001623325.
Event or Problem Description
Description: ineffective anesthesia, resolved with additional medication.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 on (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.On (b)(6) 2025: resolved with additional medication.On (b)(6) 2025: epidural placed.On (b)(6) 2025: general anesthesia.
Additional Manufacturer Narrative
Following the submission of the initial mdr, it was determined that the reported event was not reportable to the fda as it is not likely to cause or contribute to serious injury or death.If we receive any information that changes this decision, another follow up mdr will be submitted.
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: 22555628
• Report Number: 1625685-2025-00074
• Device Sequence Number: 21241961
• 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: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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