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	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Material# 405671.Batch# 0001558421.Aware date: 22nov2024.Verbatim: upon follow up from existing complaint it was reported: one anesthesia physician said that her patient could still move his legs and was sensitive to temperature.A second anesthesiologist said that he had 3 cases and two of the patients could move their legs and still had sensory functions while the third patient of his had a minimal reduction of sensory function.Reverted to general anesthesia.This record captures the three additional patients.
Additional Manufacturer Narrative
Correction: b1: reported issue is both an adverse and product problem.H1: serious injury.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation/correction: correction: following submission of initial mdr, it was identified a lot code was reported incorrectly.Section d updated to reflect unknown lot.Device evaluation: no physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated.The medication within the kit is provided by a supplier.We have notified the supplier of this incident.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• 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): 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: 20913337
• Report Number: 1625685-2024-00144
• Device Sequence Number: 15598593
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: (01)00382904056711(11)240311(17)260131(10)0001558421
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 01/14/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 405671
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: Not provided; 01/14/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 12/13/2024; 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• 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