MAUDE Adverse Event Report: CAREFUSION, INC TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795 ANESTHESIA CONDUCTION KIT

Model Number 405828

Device Problems Complete Blockage (1094); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration 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. (b)(4).

Event Description

It was reported that tray cse whit27g4. 7 we17g3. 5 swc x3795 catheter was clogged. The following information was provided by the initial reporter: material no: 405828 batch no: unknown (provided 0003177963) it was reported that the epidural catheter in the kit does not seem to be patent; unable to push meds through it. Event description per email states: epidural catheter in kit does not seem to be patent and i cannot push meds through it.

• Brand Name: TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 11067421
• MDR Text Key: 242827582
• Report Number: 1625685-2020-00101
• 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: 05/21/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Model Number: 405828
• Device Catalogue Number: 405828
• Device Lot Number: 0001377963
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial