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	07/08/2024
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.
Event or Problem Description
Material #: 405671 batch#: 0001536091 it was reported by customer that the medication in the tray was not effective ¿ forced to revert to general anesthesia for the case.Complaint received via email(s) attached.Please open a quality complaint for this bd product at corewell health.Here are the relevant event and product details: event date: 7-8-2024 event location: (b)(6) hospital, (b)(6), event description: ¿the medication in the tray was not effective ¿ forced to revert to general anesthesia for the case¿.Harm to team member or patient? no injury to my knowledge.Product name: itm-1138260 bd spinal anesthesia tray product ref: 405671.Lot number: 0001536091.Bd customer account number: (b)(6).
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation/correction: correction: following submission of initial mdr it was identified section h1 was incorrectly documented as a malfunction.Type of reportable event updated to reflect serious injury as general anesthesia was required.Three trays were provided to our quality team for investigation.The product was visually inspected, no issues were identified within any of the ampules.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001536091 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.The sterilization record was reviewed, no issues were identified.Based on the available information we are not able to identify a root cause related to our process at this time.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 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: 19740489
• Report Number: 1625685-2024-00071
• Device Sequence Number: 7776409
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: (01)00382904056711
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/01/2024

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: 08/31/2025
• Device Catalogue Number: 405671
• Device Lot Number: 0001536091
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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