MAUDE Adverse Event Report: CAREFUSION AS LVP 20D DEHP 2SS 0.2M CV; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2430-0500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one photo but no physical sample was received by our quality team for evaluation.Upon visual inspection, it was observed that there was separation between the luer lock and the tubing segment.A device history record review could not be performed on model 2430-0500 because a lot number was not provided by the customer.Root cause analysis: however, the root cause of this incident could not be determined due to no sample being returned.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that as lvp 20d dehp 2ss 0.2m cv luer loc disconnected from the tubing.The following information was provided by the initial reporter: material no: 2430-0500 batch(lot) no: unknown.It was reported luer loc disconnected from tubing segment which resulted in a chemo spill.

• Brand Name: AS LVP 20D DEHP 2SS 0.2M CV
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10192201
• Report Number: 9616066-2020-01985
• Device Sequence Number: 835510
• Product Code: FPA
• UDI-Device Identifier: 07613203011396
• UDI-Public: 7613203011396
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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
• Report Date (Section B): 06/04/2020

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 Model Number: 2430-0500
• Device Catalogue Number: 2430-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other