MAUDE Adverse Event Report: CAREFUSION 40 INCH EXT W/2 VLV PORTS; INTRAVASCULAR ADMINISTRATION SET

Model Number	30262E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that 40 inch ext w/2 vlv ports was cracked and leaking.The following information was provided by the initial reporter: material no: 30262e batch no: 20046788 it was reported the extension tubing cracked.
Additional Manufacturer Narrative
The following fields have been updated with additional information: b.4.Date event reported to cfn: 2020-06-25.G.4.Reportable aware date: 2019-06-25.
Event or Problem Description
It was reported that 40 inch ext w/2 vlv ports was cracked and leaking.The following information was provided by the initial reporter: material no: 30262e batch no: 20046788.It was reported the extension tubing cracked.

• Brand Name: 40 INCH EXT W/2 VLV PORTS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10274132
• Report Number: 9616066-2020-02172
• Device Sequence Number: 2613422
• Product Code: FPA
• UDI-Device Identifier: 07613203011471
• UDI-Public: 7613203011471
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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: Other
• Device Expiration Date: 04/24/2023
• Device Model Number: 30262E
• Device Catalogue Number: 30262E
• Device Lot Number: 20046788
• 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: 07/14/2020
• Supplement Report FDA Received Date: 08/15/2020
• 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: 20200617; 01-01-2020
• Outcome Attributed to Adverse Event: Other