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

Model Number	ME1224
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 product: (3)10ml bd poliflush sp syringe ref 306575, lot 8200563, exp 2021-07, 0.9% nacl, therapy date unk.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 set was received as an unexpected return with a change due date sticker attached to trifuse extension set that stated; " leaking." although requested, no further details were provided by the customer for this event.
Event or Problem Description
The set was received as an unexpected return with a change due date sticker attached to trifuse extension set that stated; " leaking." although requested, no further details were provided by the customer for this event.
Additional Manufacturer Narrative
The customer¿s report of leaking was confirmed.Visual inspection of the set noted no damage or any anomalies.Examination under magnification noted no issues with any of the tubing depths within the parallel connector.Functional testing confirmed leaking at the engagement between one of the three tubing's to the parallel connector component.The leak was observed at the same engagement.The root cause was identified as a sink condition in the parallel connector component (supplier issue).

• Brand Name: 6-IN STANDARDBORE TRI-FUSE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8545786
• Report Number: 9616066-2019-01067
• Device Sequence Number: 1731147
• Product Code: FPA
• UDI-Device Identifier: 10885403236112
• UDI-Public: 10885403236112
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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: ME1224
• Device Catalogue Number: ME1224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/11/2019
• 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: (3)MZ1000-07,NON-BD RED MALE LUER CAP, TD UNK; (3)MZ1000-07,NON-BD RED MALE LUER CAP, TD UNK