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

Catalog Number 405632

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Information (3190)

Event Date 02/26/2019

Event Type  malfunction  

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 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
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8425372
• MDR Text Key: 139076970
• Report Number: 1625685-2019-00017
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056322
• UDI-Public: 00382904056322
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H.10.
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405632
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other