MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	MZ5307
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
It was reported that on (b)(6) medicine transplant floor the bi-fuse was broken at the y-site junction.
Event or Problem Description
It was reported that on 12 west tower general medicine transplant floor the bi-fuse was broken at the y-site junction.
Additional Manufacturer Narrative
The customer report of a broken bifuse at the y connection (parallel connector) was confirmed.The separation was observed at the engagement between the exit port of the parallel connector and smallbore tubing components.Further inspection of the separated tubing end observed trace of solvent along with a solvent ring away from the tubing end.The root cause of the customer's report was not identified.

• Brand Name: EXTENSION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8610413
• Report Number: 9616066-2019-01295
• Device Sequence Number: 11307720
• Product Code: FPA
• UDI-Device Identifier: 10885403230615
• UDI-Public: 10885403230615
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2019

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 Model Number: MZ5307
• Device Catalogue Number: MZ5307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 07/05/2019
• 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: MP1000-C, TD (B)(6) 2019