MAUDE Adverse Event Report: CAREFUSION 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	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: broviac 4.2 fr.Catheter; syringe , microclave and one used swab cap.The event reportedly occurred in the nicu; therefore it is presumed the patient was a neonate.Initials (b)(6) listed (unknown if moms initials or md initials).Race white.The devices have 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 the "medication filter tubing", attached to a broviac 4.2 fr.Catheter at the left femoral was not clamped, a wet spot was noticed in the patient bed.Upon closer observation a leak was noted at the filter.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.Although requested the customer did not indicate any patient harm.The set was in use for less than 24 hrs.When the event occurred.The event occurred in the nicu.
Additional Manufacturer Narrative
The customer report of a filter leak was confirmed.Visual inspection of the set showed dried fluid residue within the filter component.During functional testing fluid was observed to be leaking out from the vent of the 0.2 micron filter.The root cause of the leak was determined to be oversaturation of the filter which causes the infusate to leak/weep out through the path of least resistance (the filter air vent).
Event or Problem Description
The customer reported that the "medication filter tubing", attached to a broviac 4.2 fr.Catheter at the left femoral was not clamped, a wet spot was noticed in the patient bed.Upon closer observation a leak was noted at the filter.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.Although requested the customer did not indicate any patient harm.The set was in use for less than 24 hrs.When the event occurred.The event occurred in the nicu.

• 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: 8242680
• Report Number: 9616066-2019-00041
• Device Sequence Number: 19364254
• 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,health
• 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: 03/25/2019
• 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: 8110,8015,SYR TUBING, TD (B)(6) 2018
• Patient Age: 12 MO