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

Model Number	10010570
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2018
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.The event reportedly occurred in the nicu; therefore it is presumed the patient was a neonate.Concomitant medical products: microclave, swab cap; peripheral iv, therapy date : (b)(6) 2018.
Event or Problem Description
The customer reported a leak on the side of the filter extension set of unspecified fluids when administrating an iv push.The facility went live a couple of months with the filter set however in the past 2 weeks the nicu has noticed several filter extension set complaints.
Event or Problem Description
The customer reported a leak on the side of the filter extension set of unspecified fluids when administrating an iv push.The facility went live a couple of months with the filter set however in the past 2 weeks the nicu has noticed several filter extension set complaints.
Additional Manufacturer Narrative
The customer¿s report of a leak was confirmed.Visual inspection of the set showed no damage or any anomalies.Closer inspection under magnification showed traces of insufficient solvent at the engagement of the filter outlet and the tubing.The tubing was measured and found to be within specification.The root cause of the leaking is insufficient solvent at the engagement between the filter outlet and the tubing.

• Brand Name: MICROBORE EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8242103
• Report Number: 9616066-2019-00053
• Device Sequence Number: 2125228
• Product Code: FPA
• UDI-Device Identifier: 10885403233500
• UDI-Public: 10885403233500
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 12/19/2018

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: 10010570
• Device Catalogue Number: 10010570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 03/14/2019
• 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: 8015,SYR TUBE,8110,SYRINGE, TD (B)(6) 2018