MAUDE Adverse Event Report: BECTON DICKINSON 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR; ANESTHESIA CONDUCTION KIT

Catalog Number	400866
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 400866 batch #0001566190.Customer reports that the needle failed, resulting in an incomplete procedure.The customer states, ¿the bupivacaine has caused a series of incomplete spinals¿ that block is pretty definitive as csf flows back in the needle, so unlikely to be user error.¿ customer response received on (b)(6)2025 i don¿t think the needle was the issue here.It was likely the bupivacaine that was resulting in a series of incomplete blocks.Adding dr.Hand for additional details.Customer response received on 13feb25 1.When reported "the bupivacaine has caused a series of incomplete spinals" - does that mean the anaesthesia is not numbing the patient? or is there an issue with the needle administering? the patients are not becoming ¿numb¿ as would be expected with a spinal dose of bupivacaine.One patient had little to no numbness despite appropriate flow of csf out of the needle.2.Are they completing the procedure using a new vial of medication or reverting to general anaesthesia? in both cases, the patients had to have general anesthesia, a far inferior anesthetic for a c-section.
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation/correction: correction: section h: type of reportable event changed to serious injury as event is both a malfunction and serious injury.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 0001566190 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
No additional information.

• Brand Name: 25GX3.5IN WHIT 5ML GLASPAK BUPI 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: 21410423
• Report Number: 1625685-2025-00021
• Device Sequence Number: 13089238
• Product Code: CAZ
• UDI-Device Identifier: 50382904008661
• UDI-Public: (01)50382904008661(11)240429(17)260131(10)0001566190
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: 400866
• Device Lot Number: 0001566190
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2024
• 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