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	04/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 405671, lot # 0001523530.It was reported by customer that they have experienced 2 episodes where the anesthesia was ineffective.Verbatim: rcc received a complaint via phone.Pir attached.Productcomplaint - customer called to report that the doctor advised they have experienced 2 episodes where the anesthesia was ineffective.405671 lot 0001523530 no harm to the pt, had to give additional medication to complete procedure.Samples available - 2 unused products.
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.H3 other text : see h10 manufacture narrative.
Event or Problem Description
Material # 405671.Lot # 0001523530.It was reported by customer that they have experienced 2 episodes where the anesthesia was ineffective.Verbatim: rcc received a complaint via phone.Pir attached.Product complaint - customer called to report that the doctor advised they have experienced (b)(4) episodes where the anesthesia was ineffective.405671 lot 0001523530 no harm to the pt, had to give additional medication to complete procedure.Samples available - (b)(4) unused products.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: two samples 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 0001523530 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.

• 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: 19200967
• Report Number: 1625685-2024-00042
• Device Sequence Number: 12780512
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: (01)00382904056711
• 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): 10/03/2024

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: 06/30/2025
• Device Catalogue Number: 405671
• Device Lot Number: 0001523530
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown