MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,EXTENSION,INTRAVASCULAR

Model Number 20039E

Device Problem Flushing Problem (1252)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

Although requested device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Patient information was requested, but not provided.

Event Description

It was reported that a usg piv was placed on a critical patient and after hooking up tubing and attempting to flush i was not able to, attempted to draw back and was not able to.Patient had complicated veins so i assumed it was malposition or something was wrong with the placement.Removed the piv and made another attempt and "walked" the catheter in to the hub, connected tubing again and same situation except prior to attaching tubing i pulled labs directly from the iv catheter this time so knew it was a good placement.I attached a newly connected flush and tubing to the piv and this time it was able to pull back and flush with ease.

• Brand Name: EXTENSION SET
• Type of Device: SET,EXTENSION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: mustafa omar ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9380141
• MDR Text Key: 190923509
• Report Number: 9616066-2019-03479
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203011952
• UDI-Public: 7613203011952
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2022
• Device Model Number: 20039E
• Device Catalogue Number: 20039E
• Device Lot Number: 19076433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1