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	11/18/2024
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# 0001558421 it was reported by customer that we have been informed by our anesthesiologists that the tray component (marcaine ampule) in tray lot# 0001558421 is not producing the desired results.There have been 4 instances of this same complaint, with the final complaint being this morning.All have been from the same lot number and we have 6 more trays in inventory verbatim: we have been informed by our anesthesiologists that the tray component (marcaine ampule) in tray lot# 0001558421 is not producing the desired results.There have been 4 instances of this same complaint, with the final complaint being this morning.All have been from the same lot number and we have 6 more trays in inventory.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001558421 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
Material# 405671, batch# 0001558421.It was reported by customer that we have been informed by our anesthesiologists that the tray component (marcaine ampule) in tray lot# 0001558421 is not producing the desired results.There have been 4 instances of this same complaint, with the final complaint being this morning.All have been from the same lot number and we have 6 more trays in inventory.Verbatim: we have been informed by our anesthesiologists that the tray component (marcaine ampule) in tray lot# 0001558421 is not producing the desired results.There have been 4 instances of this same complaint, with the final complaint being this morning.All have been from the same lot number and we have 6 more trays in inventory per customer response: 1.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.One anesthesia physician said that her patient could still move his legs and was sensitive to temperature.A second anesthesiologist said that he had 3 cases and two of the patients could move their legs and still had sensory functions while the third patient of his had a minimal reduction of sensory function.2.Could you please describe the issues in detail? please see answer to question 1.3.If you were able to use another vial of medication or if they had to revert to general anesthesia? reverted to general anesthesia.

• 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: 20787547
• Report Number: 1625685-2024-00132
• Device Sequence Number: 12509907
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: (01)00382904056711(11)240311(17)260131(10)0001558421
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/09/2025

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: 01/31/2026
• Device Catalogue Number: 405671
• Device Lot Number: 0001558421
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• 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