MAUDE Adverse Event Report: BECTON DICKINSON 24GX3.5IN WHIT 20G SPINAL INTRO CLEAR; ANESTHESIA CONDUCTION KIT

Catalog Number	400868
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 400868, batch#: 0001530808.When opening item#: 400868, they noticed the introducers were closed off not allowed a needle to pass through.
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.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: one tray was provided to our quality team for investigation.Through visual inspection, no issues were identified within the needles returned, we were unable to replicate the reported incident.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001530808 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.Based on the available information we are not able to identify a root cause at this time.To date, there have been no other similar events reported for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: 24GX3.5IN WHIT 20G SPINAL INTRO CLEAR
• 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: 21240543
• Report Number: 1625685-2025-00007
• Device Sequence Number: 14363069
• Product Code: CAZ
• UDI-Device Identifier: 50382904008685
• UDI-Public: (01)50382904008685(11)230824(17)250831(10)0001530808
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: 08/31/2025
• Device Catalogue Number: 400868
• Device Lot Number: 0001530808
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 03/16/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 03/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown