MAUDE Adverse Event Report: CAREFUSION 6-IN STANDARDBORE TRI-FUSE SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	ME1224
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer report of a leak from the trifuse extension sets was confirmed based on functional testing on two of the received initial unopened reported associate set samples.The reported suspect set was not received for evaluation.However, a customer-provided video confirmed the leak at the same location as that of the returned associate sets.The leaks on the two samples were observed at the engagement between one of the three tubing's to the inlet of the parallel connector components.The root cause was identified as a manufacturing issue.
Event or Problem Description
It was reported that the trifuse extension leaked when attached to a primary set and when mated to a syringe.The event occurred in the icu.Although requested there was no additional event details or patient impact provided at this time.The customer stated the leaks occurred when removing the extension set from the package and testing the set with a syringe.A video attached to file of product failure leaks when using syringe and slid clamp is clamped.
Event or Problem Description
It was reported that the trifuse extension leaked when attached to a primary set and when mated to a syringe.The event occurred in the icu.Although requested there was no additional event details or patient impact provided at this time.The customer stated the leaks occurred when removing the extension set from the package and testing the set with a syringe.A video attached to file of product failure leaks when using syringe and slid clamp is clamped.
Additional Manufacturer Narrative
Section a requested however not provided by customer.

• Brand Name: 6-IN STANDARDBORE TRI-FUSE SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9845941
• Report Number: 9616066-2020-01027
• Device Sequence Number: 19554737
• Product Code: FPA
• UDI-Device Identifier: 10885403236112
• UDI-Public: 10885403236112
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 11/18/2019

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 Expiration Date: 11/11/2022
• Device Model Number: ME1224
• Device Catalogue Number: ME1224
• Device Lot Number: 17116882
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 03/24/2020
• 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: (2)2426-0500, PRI TUBING, TD: UNK.