MAUDE Adverse Event Report: CAREFUSION VERSASAFE SPLIT SEPTUM SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10779313
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.Although requested, patient demographics were not provided.
Event or Problem Description
It was reported that a month prior, the plastic piece on top of burette broke off.Although requested, additional information was not provided.

• Brand Name: VERSASAFE SPLIT SEPTUM SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10176733
• Report Number: 9616066-2020-01923
• Device Sequence Number: 19496620
• Product Code: FPA
• UDI-Device Identifier: 10885403234279
• UDI-Public: 10885403234279
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2020

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: Health Professional
• Device Model Number: 10779313
• Device Catalogue Number: 10779313
• 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: 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1