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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cont'd from concomitant medical products: picc line; medlin; ,el-nc1001, therapy date unk.Noted nicu,the event reportedly occurred in the nicu; therefore it is presumed the patient was a neonate.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.
Event or Problem Description
The customer reported that the user flushed the medication line when a leak was noticed at the filter.It was reported that the set was attached to patient picc(1.9 fr.) line on baby's left foot.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.An incomplete event date documented as (b)(6) 2018.The event occurred in the nicu.
Event or Problem Description
The customer reported that the user flushed the medication line when a leak was noticed at the filter.It was reported that the set was attached to patient picc(1.9 fr.) line on baby's left foot.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.An incomplete event date documented as 12/2018.The event reported in the nicu.
Additional Manufacturer Narrative
Correction on initial report: concomitant medical products.
Event or Problem Description
The customer reported that the user flushed the medication line when a leak was noticed at the filter.It was reported that the set was attached to patient picc(1.9 fr.) line on baby's left foot.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.An incomplete event date documented as 12/2018.The event reported in the nicu.
Additional Manufacturer Narrative
The customer¿s report of a leak at the filter was confirmed.Visual inspection of the set showed no damage or any anomalies.Closer inspection under magnification showed no cracks, tool marks or stress marks on the filter component.Functional testing confirmed leaking from the filter side weld line.The root cause of the weld line leak is a supplier manufacturing issue.

• 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: 8242482
• Report Number: 9616066-2019-00055
• Device Sequence Number: 1582518
• 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,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; Not provided
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 01/28/2019; 03/22/2019
• 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,(2)SYRINGE, TD UNK