MAUDE Adverse Event Report: CAREFUSION, INC BD¿ WHITACRE SPINAL TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number	405675
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Pma / 510(k) #: enforcement discretion.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 packaged bd whitacre spinal trays had different items in the trays and were missing two drugs.There was no report of exposure, injury, or medical intervention noted.
Event or Problem Description
It was reported that the packaged bd whitacre spinal trays had different items in the trays and were missing two drugs.There was no report of exposure, injury, or medical intervention noted.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.2 cases (20 units) of lot 0001233692 were returned for sample evaluation.All units were visually inspected per the requirements of the bill of materials for product code (b)(4).The inspection did not identify any discrepancies with the components included in the 20 units.A review of the device history record (dhr) shows that all inspection results passed per the dhr process and no anomalies were noticed during production.The review also noted that lot 0001233692 was manufactured per a project without the bupivacaine and marcaine drug components due to supply chain disruptions with the vendor.As noted above, the investigation did note the bupivacaine and marcaine components were not included based on the manufacturing deviation per a project.Consequently, the reported defect was not confirmed per the sample analysis.No probable contributors were identified from any of the noted factors above.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.

• Brand Name: BD¿ WHITACRE SPINAL TRAY
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 7759834
• Report Number: 1625685-2018-00030
• Device Sequence Number: 228604
• Product Code: CAZ
• UDI-Device Identifier: 00382904056759
• UDI-Public: 00382904056759
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2018

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 Expiration Date: 10/31/2020
• Device Catalogue Number: 405675
• Device Lot Number: 0001233692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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