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

Model Number	MZXT9001
Medical Device Problem Codes	Component Missing (2306); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2018
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.
Event or Problem Description
Received a copy of the customer's medwatch which states, "patient in long-term care facility.Rn went to flush patient's peripheral iv in left forearm and line was occluded.On investigation it was noted that the white port on the t connector was missing the blue diaphragm piece.Line was placed on (b)(6) 2018 and occluded on (b)(6) 2018." the product was replaced, and there was no patient harm.
Additional Manufacturer Narrative
The customer¿s report of an occlusion was not confirmed.The customer¿s report that the t connector was missing the blue diaphragm piece was confirmed.Visual inspection found that the nac-t port had the blue piston missing.During functional testing the set leaked from the nac-t port where the blue piston was missing.The root cause of the customer¿s report of an occlusion could not be identified the root cause of the missing blue piston from the nac-t port was identified as a manufacturing issue due to a bad segregation during the inspection of the components.
Event or Problem Description
Received a copy of the customer's medwatch which states, "patient in long-term care facility.Rn went to flush patient's peripheral iv in left forearm and line was occluded.On investigation it was noted that the white port on the t connector was missing the blue diaphragm piece.Line was placed on (b)(6) 2018 and occluded on (b)(6) 2018." the product was replaced, and there was no patient harm.

• 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: 8380625
• Report Number: 9616066-2019-00488
• Device Sequence Number: 16551216
• Product Code: FPA
• UDI-Device Identifier: 10885403240805
• UDI-Public: 10885403240805
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• 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): 02/05/2019

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: MZXT9001
• Device Catalogue Number: MZXT9001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 07/03/2019
• 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: NON-BD CATHETER, TD (B)(6) 2018; PERIPHERAL IV, TD (B)(6) 2018
• Patient Age: 21 YR
• Patient Weight: 44