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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material# 405671 batch# 0001528811 it was reported by customer that they had issue regarding on 405671 spinal anesthesia kit which has hyperbaric bupivacaine 0.75% packaged within the kit.Verbatim: rcc received a complaint via email.Email(s) attached.Can i please request a phone call tomorrow ((b)(6)) from the bd rep who covers brigham and women¿s hospital in boston, and specifically, the l&d unit /obstetric anesthesia? i have a somewhat urgent issue regarding our 405671 spinal anesthesia kit which has hyperbaric bupivacaine 0.75% packaged within the kit.My center has had approximately 10 cases of failed spinals in the past 2 months and i¿d like to understand whether this may be isolated to this particular lot (photo below).
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
Additional information: some mds repeated a spinal.
Additional Manufacturer Narrative
Follow up mdr for additional information received from the customer.Annex e and annex f codes updated from insufficient information based on customer response.
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr for device evaluation: no physical samples were available for investigation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001528811 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.Based on the available information we are not able to identify a root cause at this time.The supplier was also notified of the reported failure mode.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: 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: 19485168
• Report Number: 1625685-2024-00058
• Device Sequence Number: 20814216
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: (01)00382904056711
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 405671
• Device Lot Number: 0001528811
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 06/04/2024; 09/09/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 06/07/2024; 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown