MAUDE Adverse Event Report: BECTON DICKINSON TRAY SPN QNKE25G3.5 B-D/L/E/P; ANESTHESIA CONDUCTION KIT

Catalog Number	405735
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Material# 405735, batch# 0001547937.Verbatim: pt was an unscheduled cesarean section for hellp at 25.2 weeks gestation.Spinal was placed by dr; patient did not get numb.Dr.Stated it is the medication in the spinal trays and to find another lot number.Another tray by a different manufacturer was found and the spinal was effective.The patient had to be poked twice due to the defective spinal tray.A general on a 25.2 week fetus would have further compromised the fetus.This also caused a delay of care as the patient had a second spinal placed and had to be prepped again.Also note that the nicu team had to be off their unit for longer than expected due to the delay of care.The defective spinal trays lot # is 0001547937.Event date: 12/23/2024 description: tray spinal anesth 25g 3.5in qnke l/e/p sample available: yes (if sample is available and would like it sent for your evaluation, please reply all, and attach a return shipping label via email) lot #: 0001547937.Was there injury? caused the patient to have multiple sticks.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: two unopened trays were provided to our quality team for investigation.The product was inspected, no external damage to the trays was observed and the vials were intact.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001547937 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.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 are not able to identify a root cause related to our process that could impact the efficacy of the medication provided within our kits.The medication within the kit is provided by a supplier.We have notified the supplier of this incident.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 QNKE25G3.5 B-D/L/E/P
• 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: 21052138
• Report Number: 1625685-2024-00153
• Device Sequence Number: 8136687
• Product Code: CAZ
• UDI-Device Identifier: 00382904057350
• UDI-Public: (01)00382904057350(11)240104(17)260131(10)0001547937
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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
• Report Date (Section B): 02/22/2025

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: 01/31/2026
• Device Catalogue Number: 405735
• Device Lot Number: 0001547937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 01/01/2025
• Supplement Report FDA Received Date: 02/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown