MAUDE Adverse Event Report: BECTON DICKINSON CATHETER W/CONN S/SU 20GA CE FOR 3-1/2IN; ANESTHESIA CONDUCTION KIT

Catalog Number	400507
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
It is reported catheter broke off in patient.Event description: material: 400507.Batch#: 2138625.Patient came in for a left knee revision.Anesthesiologist was doing a combined spinal epidural (cse).Epidural catheter tip broke off inside the space.When catheter was removed, the tip wasn't there.Notified manager and surgeon.We did an x-ray and didn't see anything.Surgeon and anesthesiologist decided to proceed with knee revision surgery and will get a neurosurgery consult afterwards.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Additional information: (b) date of event has since been provided.Investigation results: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: CATHETER W/CONN S/SU 20GA CE FOR 3-1/2IN
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22800935
• Report Number: 2243072-2025-00996
• Device Sequence Number: 8960377
• Product Code: CAZ
• UDI-Device Identifier: 00382904005078
• UDI-Public: (01)00382904005078(17)270531(10)2138625
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K953790
• 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): 11/20/2025

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 Catalogue Number: 400507
• Device Lot Number: 2138625
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown