MAUDE Adverse Event Report: CAREFUSION MINIBORE BI-FUSE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MP9027-C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
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.Although requested, patient demographics not provided.
Event or Problem Description
The customer reported the bi-fuse extension set leaked during an infusion.Although requested, no further information has been received.
Event or Problem Description
The customer reported the bi-fuse extension set leaked during an infusion.Although requested, no further information has been received.
Additional Manufacturer Narrative
The customer¿s report of the bi-fuse extension set leaked during an infusion was not confirmed.Visual inspection of the set noted no damage or any anomalies.Functional and pressure testing resulted in no leaking at any of the components, tubing, or connections.Dimensional analysis was performed and the sets were within iso specifications.The root cause of the customer¿s report of leaking was not identified.

• Brand Name: MINIBORE BI-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: 8462173
• Report Number: 9616066-2019-00896
• Device Sequence Number: 3057154
• Product Code: FPA
• UDI-Device Identifier: 10885403236907
• UDI-Public: 10885403236907
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 02/13/2019

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: MP9027-C
• Device Catalogue Number: MP9027-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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: MZ1000-07,NON-BD SET, THERAPY DATE UNK