MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN SPT24G3.5 B/L/E; ANESTHESIA CONDUCTION KIT

Catalog Number	405707
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the tray spn spt24g3.5 b/l/e caused a patient to be transferred to another hospital when "the tray was missing bupivacaine and marcaine.".
Event or Problem Description
It was reported that the tray spn spt24g3.5 b/l/e caused a patient to be transferred to another hospital when "the tray was missing bupivacaine and marcaine.".
Additional Manufacturer Narrative
Investigation summary: no sample was received from the customer.Consequently, no sample evaluation was performed in regards to the reported failure mode.A dhr review for lot 0001248934 did not identify any manufacturing defects or issues that may have contributed to the reported failure.The review did note that lot 0001248934 was included in project sd-2018-007.This project was initiated to temporarily run applicable products without the epinephrine and bupivacaine components due to supply shortages from the vendor.Based on the results of the investigation, lot 0001248934 was produced under project sd-2018-007.This project was initiated to temporarily remove the epinephrine and bupivacaine components from affected product codes due to a supply shortage from the vendor.The investigation did not identify any manufacturing defect that contributed to the reported failure mode.Since no manufacturing defect was identified, no corrective or preventive actions will be implemented for this complaint.The complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.
Event or Problem Description
It was reported that 10 tray spn spt24g3.5 b/l/e caused a patient to be transferred to another hospital when "the tray was missing bupivacaine and marcaine.".
Additional Manufacturer Narrative
Per additional information received, the number of occurrence has been updated to 10.The following information has been updated: it was reported that 10 tray spn spt24g3.5 b/l/e caused a patient to be transferred to another hospital when "the tray was missing bupivacaine and marcaine.".

• Brand Name: TRAY SPN SPT24G3.5 B/L/E
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8388227
• Report Number: 1625685-2019-00014
• Device Sequence Number: 1827831
• Product Code: CAZ
• UDI-Device Identifier: 00382904057077
• UDI-Public: 00382904057077
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: DISCRETION
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2019

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: Other
• Device Catalogue Number: 405707
• Device Lot Number: 0001248934
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 02/13/2019; 02/13/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 03/06/2019; 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other