MAUDE Adverse Event Report: CAREFUSION, INC BD¿ SPINAL TRAY

Catalog Number	405733
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k)#: enforcement discretion.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd¿ spinal tray was missing label information.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: no samples were provided for evaluation.However, the bupivacaine and marcaine drug components were intentionally removed per an internal project due to supply chain disruption.Based on the complaint investigation results, no probable root cause associated with the manufacturing process was identified.Since no probable root cause was identified, no corrective and/or preventive actions were identified for this complaint.This complaint will be added to the complaint management system and will be tracked & trended for future occurrences through the quality data analysis process.A review of the device history record shows that all inspection results passed per the dhr process and no anomalies were noticed during production.The review also noted that lot 0001253521 was manufactured per a project without the bupivacaine and marcaine drug components due to supply chain disruptions with the vendor.
Event or Problem Description
It was reported that bd¿ spinal tray was missing label information.No serious injury or medical intervention was reported.

• Brand Name: BD¿ SPINAL TRAY
• Common Device Name: SPINAL TRAY
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 7974545
• Report Number: 1625685-2018-00045
• Device Sequence Number: 10805640
• Product Code: CAZ
• UDI-Device Identifier: 00382904057336
• UDI-Public: 00382904057336
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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: 01/31/2021
• Device Catalogue Number: 405733
• Device Lot Number: 0001253521
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/12/2018
• 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