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

Model Number MZ9226

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that fluid leak was found at the filter.The tubing was disconnected from y-site and the line was clamped.The event occurred in neonatal intensive care unit (nicu).There was no patient injury.Although requested, additional information was not provided.

Manufacturer Narrative

Additional information provided: d.10 & d.11.The customer's report of leak at filter was confirmed.The set sample was visually inspected for kinks, holes/tears in the tubing or damages to the components.Brownish colored dried fluid residue was observed around the filter weld.Visual inspection of the maxzero extension set noted no damage or any anomalies.Examination under magnification of the filter observed the top assembly not fully secured to the bottom assembly.No obvious damage or issue was observed.Functional testing confirmed leaking from the weld of the micron filter.The root cause was determined to be due to a supplier issue of the ultrasonic weld area of the filter.

Event Description

It was reported that fluid leak was found at the filter.The tubing was disconnected from the y-site and the line was clamped.The event occurred in neonatal intensive care unit (nicu).It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.Although requested, additional event information was not provided.

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR,.F
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9532842
• MDR Text Key: 191111535
• Report Number: 9616066-2019-03778
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

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: 12/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALCOHOL CAP, THERAPY DATE (B)(6) 2019