MAUDE Adverse Event Report: CAREFUSION, INC BD CONTINUOUS EPIDURAL TRAY

Catalog Number 400840

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

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

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown. Device expiration date: unknown. Device manufacture date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a 18gx3. 5 weiss 20g ce,5ml lor ll,27g hyp had a difficult epidural connector. The following was reported, "material no. : 400840. Batch/lot: unknown/ not provided. It was reported that "providers are having issues with the epidural connector - it¿s difficult to put on the epidural line to the point where it¿s been falling off the line and issues of the provider tightening it too much which has been constricting the line not allowing the medicine to go through the line. ".

• Brand Name: BD CONTINUOUS EPIDURAL TRAY
• Type of Device: EPIDURAL TRAY
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8493792
• MDR Text Key: 141448374
• Report Number: 1625685-2019-00020
• Device Sequence Number: 0
• Product Code: CAZ
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 400840
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/08/2019 Patient Sequence Number: 1