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

Model Number	MZ9265
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mz9271; non-bd picline and a 10ml bd syringe; td (b)(6) 2018.The product has been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
The customer reported that fluid leaked from above the luer lock on bi-fuse set.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report of leaking was confirmed.Visual inspection and functional testing showed no anomalies.Pressure testing showed a leak at the connection between the male luer of a concomitant extension set and the female port of the maxzero extension set.Closer inspection of the maxzero under magnification showed a microchannel that was allowing fluid to leak out.The root cause of the microchannel was an equipment error during the inspection and testing process.
Event or Problem Description
The customer reported that fluid leaked from above the luer lock on bi-fuse set.There was no report of patient harm.

• Brand Name: EXTENSION SET
• Common Device Name: SET,EXTENSION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7745442
• Report Number: 9616066-2018-01240
• Device Sequence Number: 11160112
• Product Code: FPA
• UDI-Device Identifier: 10885403240744
• UDI-Public: 10885403240744
• 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: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2018

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: MZ9265
• Device Catalogue Number: MZ9265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 11/07/2018
• 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: MZ1000-07(2),10014914,8015,8110,TD: (B)(6) 2018; MZ9271, TD (B)(6) 2018
• Patient Age: 11 DA