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

Model Number 37262E

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted with failure investigation results should the product be received for evaluation.

Event Description

Customer advocacy received a copy of the customer's medwatch report from the fda which states, "a (b)(6) male came to critical care directly from a cvor procedure for atrial septal defect closure.Upon arrival to clinical care, nursing noticed that it appeared that the blood extension tubing connector had broken off inside the tubing where the tubing connects to the central venous catheter (cvl).The nurse was able to clamp that port and claim it unusable while notifying the md.When the md came, decision was made to replace the cvl.Fda safety report id# (b)(4).".

• Brand Name: ALARIS 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: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9527720
• MDR Text Key: 174314538
• Report Number: 9616066-2019-03758
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403235276
• UDI-Public: 10885403235276
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2022
• Device Model Number: 37262E
• Device Catalogue Number: 37262E
• Device Lot Number: 19066289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2019
• 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
• Patient Outcome(s): Required Intervention