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	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Concomitant medical products: microclave and one used swab cap; broviac catheter, syringe (iv push, device syringe).
Event or Problem Description
The customer reported that the user was giving an iv push medication when the filter "busted".The filter line was attached to the patients right ij broviac (2.7 fr.) 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.There was no report of patient harm.
Event or Problem Description
The customer reported that the user was giving an iv push medication when the filter "busted".The filter line was attached to the patients right ij broviac (2.7 fr.) 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.
Additional Manufacturer Narrative
The customer¿s report of damage to the filter was confirmed.Visual inspection via microscope showed that the 0.2 micron filter had a crack along the side weld line between the upper and lower housing on the filter¿s output port side.Functional testing verified a leak at the location of the weld line between the upper and lower housing.The root cause of the crack was not determined.

• 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: 8242703
• Report Number: 9616066-2019-00111
• Device Sequence Number: 16542618
• 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