MAUDE Adverse Event Report: CAREFUSION MICROBORE EXTENSION SET, IV CONNECTOR,.F; SET, EXTENSION, INTRAVASCULAR

Model Number MZ9226

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2018

Event Type  malfunction  

Manufacturer Narrative

The product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is complete.

Event Description

The customer reported that on the cvicu, the sets were attached to a cvp line.The rn saw the tubing of the cvp, the extension set, and "push port" had backed up with blood.There was a leak around the air filter in the extension set.The set was replaced with another extension set which cracked and leaked.There was no patient harm.

Manufacturer Narrative

The customer¿s report of a leak around the air filter was confirmed.Visual inspection of the set showed no damage or any anomalies.Functional and pressure testing confirmed leaking from the filter weld.The root cause was determined to be a supplier issue regarding the ultrasonic weld area of the filter.

Event Description

The customer reported that on the cvicu, the sets were attached to a cvp line.The rn saw the tubing of the cvp, the extension set, and "push port" had backed up with blood.There was a leak around the air filter in the extension set.The set was replaced with another extension set which cracked and leaked.There was no patient harm.

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR,.F
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7923331
• MDR Text Key: 122649066
• Report Number: 9616066-2018-01843
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403240621
• UDI-Public: 10885403240621
• Combination Product (y/n): N
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ9226
• Device Catalogue Number: MZ9226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MZ1000-07,CVP LINE, THERAPY DATE : (B)(6) 2018