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

Model Number	ME1032
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
The customer reported that the nurse noted that blood was backing up into the patient's arterial line.Upon assessment it was found that while flushing the arterial line the tubing leaked from the junction of the tubing and the female luer.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report of a leak at the junction of the tubing and the female luer was confirmed.Visual inspection showed no damage or anomalies with the set or its components.Examination under magnification showed insufficient solvent at the engagement.Functional testing confirmed leaking at the engagement of the tubing and the female luer.The tubing measured within specification.The root cause of the leak is insufficient solvent application.
Event or Problem Description
The customer reported that the nurse noted that blood was backing up into the patient's arterial line.Upon assessment it was found that while flushing the arterial line the tubing leaked from the junction of the tubing and the female luer.There was no report of patient harm.

• Brand Name: MINOBORE EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8020040
• Report Number: 9616066-2018-02061
• Device Sequence Number: 1369406
• Product Code: FPA
• UDI-Device Identifier: 10885403235979
• UDI-Public: 10885403235979
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 10/05/2018

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: ME1032
• Device Catalogue Number: ME1032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 01/11/2019
• 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: ARTERIAL LINE, THERAPY DATE UNK