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

Model Number	10010570
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: broviac( 2.7 french ) catheter, (2) syringes( ivp syringe/device syringe) microclave.The event reportedly occurred in the nicu; therefore it is presumed the patient was a neonate, baby boy, race w.Initial (b)(6).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 the user was administrating ivp phenobarbital when the filter "busted".The iv line was attached to a broviac (2.7 fr.Right ij) catheter.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 event occurred in the nicu.
Additional Manufacturer Narrative
The customer¿s report of damage to the filter was not confirmed however a leak at the filter vent was confirmed.The set was visually inspected and clear liquid was observed in the tubing and 0.2 micron filter.There was no damage observed.During functional testing and pressure testing drops of fluid were observed to be leaking out of the filter vent.The root cause of the leak was identified as the fluid resistance of the filter becoming roughly equivalent to the fluid resistance of the air vent, increasing backpressure at which time the fluid seeks the path of least resistance through the filter vent.
Event or Problem Description
The customer reported the user was administrating ivp phenobarbital when the filter "busted".The iv line was attached to a broviac (2.7 fr.Right ij) catheter.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 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: 8242704
• Report Number: 9616066-2019-00112
• Device Sequence Number: 13991913
• 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: 5 MO