MAUDE Adverse Event Report: CAREFUSION MAXZERO EXTENSION SET; 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	05/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the affected product be received for evaluation.
Event or Problem Description
The customer reported that an infusion of epinephrine which was infusing at 0.3ml/hr was noted to be leaking during the day shift and was replaced with a new set which was noted to be leaking later in the day.A new set of tubing and syringe were provided with no further reports of leaking.The line was connected a patient's picc line that flushed well.There was no patient harm.
Event or Problem Description
The customer reported that an infusion of epinephrine which was infusing at 0.3ml/hr was noted to be leaking during the day shift and was replaced with a new set which was noted to be leaking later in the day.A new set of tubing and syringe were provided with no further reports of leaking.The line was connected a patient's picc line that flushed well.There was no patient harm.

• Brand Name: MAXZERO EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7679485
• Report Number: 9616066-2018-01001
• Device Sequence Number: 13795611
• Product Code: FPA
• UDI-Device Identifier: 10885403233500
• UDI-Public: 10885403233500
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

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: 07/11/2018
• Supplement Report FDA Received Date: 08/09/2018
• 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: 10010570; MZ5306,PICC,SYRINGE, THERAPY DATE: (B)(6) 2018