MAUDE Adverse Event Report: CAREFUSION AS LVP 10D 3SS 2CV; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2452-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.The customer complaint of the distal connection breaking could not be verified due to the product not being returned for failure investigation.A device history record review for model 2452-0007 lot number 19115322 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 04nov019.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Root cause analysis: the root cause of this failure was not identified as no product was 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 10d 3ss 2cv was damaged.The following information was provided by the initial reporter: material #: 2452-0007 batch #: 19115322.It was reported a broken distal connection.

• Brand Name: AS LVP 10D 3SS 2CV
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10238990
• Report Number: 9616066-2020-02178
• Device Sequence Number: 11384009
• Product Code: FPA
• UDI-Device Identifier: 10885403219870
• UDI-Public: 10885403219870
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/04/2022
• Device Model Number: 2452-0007
• Device Catalogue Number: 2452-0007
• Device Lot Number: 19115322
• 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: 07/07/2020
• 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: 01-01-2020
• Outcome Attributed to Adverse Event: Other