MAUDE Adverse Event Report: CAREFUSION, INC BD SPINAL ANESTHESIA TRAY - BD WHITACRE SPINAL NEEDLE 25 G; ANESTHESIA CONDUCTION KIT

Catalog Number 405671

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Insufficient Information (4580)

Event Date 08/09/2023

Event Type  Injury  

Event Description

It was reported while using bd spinal anesthesia tray - bd whitacre spinal needle 25 g the anesthesia did not work properly.There was no report of patient impact.The following information was provided by the initial reporter: verbatim from (b)(4): customer have been experiencing failed spinals despite proper administration from various providers.This is more than coincidence; it is more of a pattern.I have been told this has happened in the past as well.We suspect that the bupivacaine medication in the kits are being rendered inactive from extreme heat/ sun exposure.Was there any adverse event or serious injury reported? - change in anesthetic plan for the patient which delayed procedure start, prolonged recovery and affect outcomes.Was there any medical/surgical intervention needed due to the event? - yes patient had to undergo general anesthesia.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: 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 0001514100 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.Supplier was also notified of the reported failure mode.

Event Description

It was reported while using bd spinal anesthesia tray - bd whitacre spinal needle 25 g the anesthesia did not work properly.There was no report of patient impact.The following information was provided by the initial reporter: verbatim from (b)(4): customer have been experiencing failed spinals despite proper administration from various providers.This is more than coincidence; it is more of a pattern.I have been told this has happened in the past as well.We suspect that the bupivacaine medication in the kits are being rendered inactive from extreme heat/ sun exposure.Was there any adverse event or serious injury reported? - change in anesthetic plan for the patient which delayed procedure start, prolonged recovery and affect outcomes.Was there any medical/surgical intervention needed due to the event? - yes patient had to undergo general anesthesia.

• Brand Name: BD SPINAL ANESTHESIA TRAY - BD WHITACRE SPINAL NEEDLE 25 G
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17666084
• MDR Text Key: 322473670
• Report Number: 1625685-2023-00084
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: (01)00382904056711
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405671
• Device Lot Number: 0001514100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention