MAUDE Adverse Event Report: CAREFUSION TRI-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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
It was reported that the extension set leaked at the connection to an unspecified mating device.Although blood and iv fluids leaked onto the patient's clothing, there were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
Correction: d.1, d.4 additional information: d.11 the customer¿s report that the extension set leaked at the connection was confirmed.However, the leak was at an engagement within the set, and not at a connection to a mating component, as reported by the customer.Residual blood was observed on the surface of the set¿s engagement between the 4-way connector and tubing, also confirming the customers report of blood leaking.Functional testing confirmed leakage at the engagement between the 4-way connector and tubing where the residual blood was initially observed.The primary set that was in use during the customer event was not returned for evaluation.Closer inspection under a lab microscope of the leak observed insufficient solvent at the engagement.The tubing¿s outside diameter was measured and found to be within measurement specification.The root cause of the leak was identified as a sink condition in the connector (supplier issue).
Event or Problem Description
It was reported that the extension set leaked at the connection to an unspecified mating device.Although blood and iv fluids leaked onto the patient's clothing, there were no adverse effects caused to the patient from the event.

• Brand Name: TRI-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: 9913455
• Report Number: 9616066-2020-01149
• Device Sequence Number: 19615895
• Product Code: FPA
• UDI-Device Identifier: 10885403237003
• UDI-Public: 10885403237003
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: 03/20/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 07/06/2020
• 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) MP1000-C; PRI TUBING, THERAPY DATE UNKNOWN