MAUDE Adverse Event Report: CAREFUSION, INC BD¿ CONTINUOUS EPIDURAL TRAY: BD PERISAFE¿ NYLON EPIDURAL CATHETER; ANESTHESIA CONDUCTION KIT CATHETER

Catalog Number 400841

Device Problems Loose or Intermittent Connection (1371); Separation Problem (4043)

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

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.(b)(6).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: bd perisafe¿ nylon epidural catheter had loose closure at the connection with the catheter allowing the connection to separate.No serious injury or medical intervention was reported.

Event Description

It was reported that bd¿ continuous epidural tray: bd perisafe¿ nylon epidural catheter had loose closure at the connection with the catheter allowing the connection to separate.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 manufacture: no.

• Brand Name: BD¿ CONTINUOUS EPIDURAL TRAY: BD PERISAFE¿ NYLON EPIDURAL CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT CATHETER
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 7789784
• MDR Text Key: 117569736
• Report Number: 1625685-2018-00034
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 400841
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other