MAUDE Adverse Event Report: BECTON DICKINSON TRAY SPN SPT24G3.5 L/B-D/E; ANESTHESIA CONDUCTION KIT

Catalog Number	405637
Medical Device Problem Codes	Defective Component (2292); Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
Event or Problem Description
Material#: 405637 batch#: 0001519886 it was reported by customer that the drug bupivacaine was not working on the patient from the bd spinal tray material# 405637 (possibly) lot# 0001519886 verbatim: the drug bupivacaine was not working on the patient from the bd spinal tray material# 405637 (possibly) lot# 0001519886 additional information received 25jan2024: the patient required general anesthesia for the procedure.2.The patient required general anesthesia, which also delayed the procedure by about 5 minutes.3.A photo of the lot number was provided.The vial was discarded after use.4.There was no known clinical adverse outcome.5.General anesthesia 6.Stable, discharged home and recovering from procedure.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
No samples or photos received for investigation.A device history review was performed for lot 1519886, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples from the same lot were evaluated, no issues or defects observed.The sterilization release record was reviewed for the finished good trays, the requirements for it's release were met.Based on the investigation results, no manufacturing related defects could be identified and therefore, a cause for the reported incident could not be determined.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Manufacturing personnel have been notified of this incident to increase awareness.

• Brand Name: TRAY SPN SPT24G3.5 L/B-D/E
• 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: 18594595
• Report Number: 1625685-2024-00012
• Device Sequence Number: 8182681
• Product Code: CAZ
• UDI-Device Identifier: 00382904056377
• UDI-Public: (01)00382904056377
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 03/11/2024

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: 10/31/2024
• Device Catalogue Number: 405637
• Device Lot Number: 0001519886
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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