MAUDE Adverse Event Report: CAREFUSION NEEDLE FREE VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	82113E
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
It was reported that the burette cracked during an ivig infusion, no medication was comprised.No patient harm.
Additional Manufacturer Narrative
The customer¿s report of the burette cracked during an ivig infusion was confirmed.Visual inspection of the set noted a 2.4320 inch crack along the volume graduation markings of the burette chamber.There were no other anomalies observed.Functional testing was deemed unnecessary due to the damage to the burette chamber.The root cause of the cracked burette was not determined.
Event or Problem Description
It was reported that the burette cracked during an ivig infusion, no medication was comprised.No patient harm.Although requested, no further information was received.

• Brand Name: NEEDLE FREE VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8496065
• Report Number: 9616066-2019-00989
• Device Sequence Number: 1780881
• Product Code: FPA
• UDI-Device Identifier: 07613203009591
• UDI-Public: 7613203009591
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K780130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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: 82113E
• Device Catalogue Number: 82113E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1