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	Anxiety (2328)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Materials#: 400866 batch#: 0001517987.It was reported by the customer that spinal anesthesia was inadequate.Verbatim: rcc received a complaint via email.Email(s) attached.Describe event or problem: patient schedule for elective post-partum tubal ligation under spinal anesthesia.Procedure described in pse as easy spinal with easy aspiration prior to and after injection of intrathecal anesthetic (bupivacaine 0.75% with dextrose 8.25%).Despite typical dose used (12 mg), trendellenderg position, and adequate time used to set up, spinal anesthesia was inadequate.Patient became very anxious and decision to proceed to geta was made.Date of event: 30-nov-2023.
Additional Manufacturer Narrative
Pr (b)(4): 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
Pr (b)(4) follow up mdr for device evaluation/correction: b.3 event date updated to correct date reported 30nov2023.Device evaluation : no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001517987 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Retain samples were analyzed, per the drug retain visual examination procedure, and no issues were identified.Based on the available information we are not able to identify a root cause at this time.We have notified the supplier of the reported incident.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
Materials#: 400866; batch#: 0001517987.It was reported by the customer that spinal anesthesia was inadequate.Verbatim: rcc received a complaint via email.Email(s) attached.Describe event or problem: patient schedule for elective post-partum tubal ligation under spinal anesthesia.Procedure described in pse as easy spinal with easy aspiration prior to and after injection of intrathecal anesthetic (bupivacaine 0.75% with dextrose 8.25%).Despite typical dose used (12 mg), trendelenberg position, and adequate time used to set up, spinal anesthesia was inadequate.Patient became very anxious and decision to proceed to geta was made.Date of event: 30-nov-2023.

• 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: 18528188
• Report Number: 1625685-2024-00006
• Device Sequence Number: 18074490
• Product Code: CAZ
• UDI-Device Identifier: 50382904008661
• UDI-Public: (01)50382904008661
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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: 06/30/2025
• Device Catalogue Number: 400866
• Device Lot Number: 0001517987
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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