MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN QNKE22G3.5 L/B-D/E; ANESTHESIA CONDUCTION KIT

Catalog Number	405609
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.The customer's address is unknown.Unknown, (b)(6), 00000 usa has been used as a default.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the tray spn qnke22g3.5 l/b-d/e label did not state that it contained bupivacaine, while another tray label did.The missing information was noticed before use.The following information was provided by the initial reporter: "health professional stated that she has two of the same 405609 tray (was not provided lot # but said it could be obtained) and one label stated it contains bupivacaine while the other did not say this.".
Additional Manufacturer Narrative
Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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.Our business team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.A device history review could not be completed as no batch number was provided.
Event or Problem Description
It was reported that the tray spn qnke22g3.5 l/b-d/e label did not state that it contained bupivacaine, while another tray label did.The missing information was noticed before use.The following information was provided by the initial reporter: "health professional stated that she has two of the same 405609 tray (was not provided lot # but said it could be obtained) and one label stated it contains bupivacaine while the other did not say this.".

• Brand Name: TRAY SPN QNKE22G3.5 L/B-D/E
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8897949
• Report Number: 1625685-2019-00093
• Device Sequence Number: 2731049
• Product Code: CAZ
• UDI-Device Identifier: 00382904056094
• UDI-Public: 00382904056094
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: DISCRETION
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: Health Professional
• Device Catalogue Number: 405609
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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