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

Catalog Number	406049
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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¿ continuous epidural tray epid cont we18g3.5 c20 lor5 p drape had a failing connector that separated.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
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.Investigation conclusion: unable to determine a root cause.Correction: due to an it issue beginning on 7/3/2018, 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 manufacturer: no.
Event or Problem Description
It was reported that bd¿ continuous epidural tray epid cont we18g3.5 c20 lor5 p drape had a failing connector that separated.No serious injury or medical intervention was reported.

• Brand Name: BD¿ CONTINUOUS EPIDURAL TRAYS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 7789877
• Report Number: 1625685-2018-00035
• Device Sequence Number: 16521584
• Product Code: CAZ
• UDI-Device Identifier: 00382904060497
• UDI-Public: 00382904060497
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2018

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: 406049
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 09/10/2018
• 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