MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN QNKE26G3.5 L/B-D; ANESTHESIA CONDUCTION KIT

Catalog Number	405632
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Pma / 510(k)#: enforcement discretion.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history review could not be completed as no batch number was provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Investigation conclusion: based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
Event or Problem Description
It was reported that the tray spn qnke26g3.5 l/b-d was noticed to have incorrect content within it before use, as it did not contain "bupivacaine".As reported by the customer, "per customer, reported the pack had the wrong contents in the pack.The pack they received did not contain bupivacaine.".

• Brand Name: TRAY SPN QNKE26G3.5 L/B-D
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8425372
• Report Number: 1625685-2019-00017
• Device Sequence Number: 16203124
• Product Code: CAZ
• UDI-Device Identifier: 00382904056322
• UDI-Public: 00382904056322
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2019

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: 405632
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/15/2019
• 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