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	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: microclave, ivp syringe, device syringe and broviac catheter.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 when attaching the syringe to the "med tubing" to administer an ivp medication, a leak was noticed at the filter site.The medication line was attached to broviac 4.2 fr.Catheter, placed at the baby's right chest wall.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 there was no indication from the customer of patient harm.The vent occurred in the nicu.
Additional Manufacturer Narrative
The customer report of a leak at the filter site was confirmed.Visual inspection showed dried fluid residue within the filter component.Functional testing resulted in leaking from the top and bottom of the filter weld line.The root cause of the weld line leak was a supplier manufacturing issue of the filter component.
Event or Problem Description
The customer reported that when attaching the syringe to the "med tubing" to administer an ivp medication, a leak was noticed at the filter site.The medication line was attached to broviac ( 4.2 fr.) catheter, placed at the baby's right chest wall.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 there was no indication from the customer of patient harm.The event occurred in 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: 8242702
• Report Number: 9616066-2019-00114
• Device Sequence Number: 19246955
• 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: 03/26/2019
• 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: 4 MO