MAUDE Adverse Event Report: BECTON DICKINSON TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE-; Anesthesia Conduction kit

Catalog Number	405671
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Numbness (2415); Respiratory Insufficiency (4462)
Date of Event	07/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, tray spn whit25g3.5 l/b-d/e plast drape, medication caused ascending numbness and respiratory depression.The following was provided by the initial reporter: complaint via phone.Patient had an urgent c-section.The anesthesiologist was given an intrathecal injection and the medication caused an ascending numbness and respiratory depression.In the last two weeks there have been 3 or 4 cases of this.This is the first case where they saved the lot and expiration for me to report.Patient had breathing difficulty, the csection had to be delayed.The patient was put in an upright position to prevent further migration of the intrathecal injection.Additional information: total number of occurrences? 3-4, but only the latest one had the lot and reference number saved.Was there any medical intervention needed, besides the placing patient in upright position? delay in emergency c-section.Oxygen.No additional reversal medications used.Was a new tray used to complete procedure? a new tray was used in the procedure.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE-
• Common Device Name: Anesthesia Conduction kit
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50208690
• Report Number: 2243072-2026-00559
• Device Sequence Number: 14839135
• Product Code: CAZ
• UDI-Device Identifier: 50382904056716
• UDI-Public: (01)50382904056716(10)B01W149D
• Combination Product (Y/N): Y
• Initial Reporter State: AK
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 405671
• Device Lot Number: B01W149D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown