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

Model Number	11088483
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
Concomitant medical products: unknown t-connector and iv access device; td unk the customer¿s report that the needleless connector leaked was confirmed.Visual inspection showed no anomalies.Functional pressure testing replicated a leak from two of the three extension sets model 11088483 that were labeled with medical tape indicating ¿leak¿.The leaks were observed on the two separate sets at the connection between the smartsite connectors and the sets' female luers.The root cause of the leak is due to a discontinuous surface contact caused by a molding defect in the female luer of extension set model 11088483.
Event or Problem Description
It was reported several different leaks occurred at the needleless connectors during a patient's infusion with several medications.There was no patient harm.Three needleless connectors were attached to microbore extension tubings.Two of these needleless connectors had a piece of tape with "leak" noted.The extensions were attached to three additional needleless connectors on the ends of a trifuse extension set.The lines were labeled "fentanyl," "versed," and "intermittent." the fentanyl and versed lines had a piece of tape with "leak" noted next to the needleless connector.The male end of the trifuse had a label indicating that it had been attached to a t-connector extension set leading to the patient's iv access device.
Event or Problem Description
It was reported several different leaks occurred at the needleless connectors during a patient's infusion with several medications.There was no patient harm.Three needleless connectors were attached to microbore extension tubings.Two of these needleless connectors had a piece of tape with "leak" noted.The extensions were attached to three additional needleless connectors on the ends of a trifuse extension set.The lines were labeled "fentanyl," "versed," and "intermittent." the fentanyl and versed lines had a piece of tape with "leak" noted next to the needleless connector.The male end of the trifuse had a label indicating that it had been attached to a t-connector extension set leading to the patient's iv access device.

• 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: 9322251
• Report Number: 9616066-2019-03205
• Device Sequence Number: 2523855
• Product Code: FPA
• UDI-Device Identifier: 10885403234668
• UDI-Public: 10885403234668
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

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: 11088483
• Device Catalogue Number: 11088483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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: 11088483,10839681,(2)2000E, TD UNK