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

Model Number	MZXT9001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.Age: adult.No other patient information will be provided.This mdr is related to mdr: (b)(4).
Event or Problem Description
It was reported that t-connectors leaked twice from the distal valve.This resulted in a delay in care as a "different means to inject" had to be utilized.There was no patient harm.
Event or Problem Description
It was reported that t-connectors leaked twice from the distal valve.This resulted in a delay in care as a "different means to inject" had to be utilized.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.
Additional Manufacturer Narrative
Additional information added; d.10.The customer's report that the t-connectors leaked from the distal valve was not confirmed.Visual inspection of the associate samples noted no damage or any anomalies.Pressure testing confirmed leaking.Examination under magnification of the leaking maxzero connector observed a microchannel/scratch within its interior diameter.The cause of the leak was due to a microchannel/scratch within the interior diameter of the maxzero connector.The root cause of the microchannel, which creates a fluid path, is due to an equipment error during the inspection and testing process during final assembly of the maxzero component.The suspect set was not returned for investigation.

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR, T
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9466769
• Report Number: 9616066-2019-03629
• Device Sequence Number: 16910867
• Product Code: FPA
• UDI-Device Identifier: 10885403240805
• UDI-Public: 10885403240805
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/25/2021
• Device Model Number: MZXT9001
• Device Catalogue Number: MZXT9001
• Device Lot Number: 18057603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1