MAUDE Adverse Event Report: CAREFUSION, INC BD COMBINED SPINAL & EPIDURAL TRAYS ¿; ANESTHESIA CONDUCTION KIT

Catalog Number	405823
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.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 before use of the bd combined spinal & epidural trays ¿ there was a sterility breach.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
One sample was received for evaluation.Visual evaluation of the complaint sample confirmed the presence of debris on the gauze component.The investigation was not able identify the most probable source for the debris since the gauze component is supplied by an external vendor and is not altered by the manufacturing facility prior to placement in the finished good tray.Based on the investigation results, the vendor of the gauze component will be notified of this failure mode through the supplier quality notification process.Likewise, all applicable manufacturing associates will receive awareness training regarding the identified failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.A review of the device history record shows that all inspection results passed per the dhr process and no anomalies were noticed during production.
Event or Problem Description
It was reported that before use of the bd combined spinal & epidural trays there was a sterility breach.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD COMBINED SPINAL & EPIDURAL TRAYS ¿
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 7971210
• Report Number: 1625685-2018-00043
• Device Sequence Number: 16481998
• Product Code: CAZ
• UDI-Device Identifier: 00382904058234
• UDI-Public: 00382904058234
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: D219092
• 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): 12/17/2018

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 Catalogue Number: 405823
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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