MAUDE Adverse Event Report: CAREFUSION MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MZ5306
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: (3) mz1000-07, therapy date: (b)(6) 2018.Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
Event or Problem Description
The customer reported the night rn noted pge leaking at the "pigtail".The nurse had to request a new pge from pharmacy and replace the tubing the pge was infusing through.The customer later reported the "pigtail" is a mz5306.There was no patient harm.
Event or Problem Description
The customer reported the night rn noted pge leaking at the "pigtail".The nurse had to request a new pge from pharmacy and replace the tubing the pge was infusing through.The customer later reported the "pigtail" is a mz5306.There was no patient harm.

• Brand Name: MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7833029
• Report Number: 9616066-2018-01476
• Device Sequence Number: 1703763
• Product Code: FPA
• UDI-Device Identifier: 10885403230592
• UDI-Public: 10885403230592
• 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): 08/05/2018

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: MZ5306
• Device Catalogue Number: MZ5306
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1