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

Catalog Number 400831

Device Problems Loose or Intermittent Connection (1371); Material Separation (1562)

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

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.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 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

Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.A device history review could not be completed as no batch number was provided.Investigation conclusion: no root cause can be determined as no samples were received.Correction: due to an it issue beginning on (b)(6) 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: 7789920
• MDR Text Key: 117442240
• Report Number: 1625685-2018-00036
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 09/10/2018

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
• Device Operator: Other
• Device Catalogue Number: 400831
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 08/01/2018
• Supplement Dates FDA Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other