MAUDE Adverse Event Report: CAREFUSION MICROBORE BI-FUSE EXTENSION SET, 2 IV CO; SET, EXTENSION, INTRAVASCULAR

Model Number	MZ9271
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2018
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 a patient had a right leg double lumen picc with tpn, lipids and prostin infusing.During patient assessment, a wet spot was found on the patient¿s linen, the cap end of the filter was found wet from leakage of tpn.A new filter primed with patient ivf and reconnected to patient picc.There was no report of patient harm.
Event or Problem Description
The customer reported that a patient had a right leg double lumen picc with tpn, lipids and prostin infusing.During patient assessment, a wet spot was found on the patient¿s linen, the cap end of the filter was found wet from leakage of tpn.A new filter primed with patient ivf and reconnected to patient picc.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report of a leak from the cap end of the filter was confirmed.Visual inspection of the set did not reveal any discernible signs of damage or abnormalities.Examination under magnification revealed evidence of interior damage near the top edge of the valve body.The damage had the appearance of a scratch.Functional testing resulted in no leaking.Pressure testing confirmed a slow leak began to form around the top of the maxzero valve body bonded at the top of the tubing arm.The cause of the leak was identified to be damage to the interior of the maxzero valve body.The root cause was determined to be equipment error occurring during the automated assembly of the maxzero component.

• Brand Name: MICROBORE BI-FUSE EXTENSION SET, 2 IV CO
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7731846
• Report Number: 9616066-2018-01185
• Device Sequence Number: 1511138
• 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: MZ9271
• Device Catalogue Number: MZ9271
• 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: 07/30/2018
• Supplement Report FDA Received Date: 10/29/2018
• 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: PRI TUBING, 8015, 8100, PICC, TD (B)(6) 2018; PRI TUBING, 8015, 8100, PICC, TD (B)(6) 2018
• Patient Age: 26 DA