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

Catalog Number 406049

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2018

Event Type  malfunction  

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 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.

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 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
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 7789877
• MDR Text Key: 117449110
• Report Number: 1625685-2018-00035
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904060497
• UDI-Public: 00382904060497
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 406049
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other