MAUDE Adverse Event Report: CAREFUSION MAXGUARD MULTI-FUSE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	ME1224
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report of a faulty 3 way leaking was confirmed.Functional testing as received replicated a leak at the engagement between the 4-way connector and tubing.Visual inspection under magnification observed a sink condition in which there is a space/gap in between the tubing and the connector (corresponding to the engagement where the leak was observed), thus creating a fluid path and the observed leak.The tubing¿s outside diameter was measured and found to be within measurement specification.The root cause of the leak was a manufacturing issue of a sink condition in the connector.
Event or Problem Description
The customer provided a photo with note attached to a trifuse extension set that stated: "faulty 3 way leaking from under pink tape." an event date of (b)(6) and bed 1 was also documented on the note.Although requested the customer did not indicate any patient harm or medical interventions rendered.The event occurred in the icu.

• Brand Name: MAXGUARD MULTI-FUSE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8595771
• Report Number: 9616066-2019-01150
• Device Sequence Number: 14039932
• Product Code: FPA
• UDI-Device Identifier: 10885403236112
• UDI-Public: 10885403236112
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2018

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
• Operator of Device: Health Professional
• Device Model Number: ME1224
• Device Catalogue Number: ME1224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (3)MZ1000-07, TD (B)(6) 2018