MAUDE Adverse Event Report: CAREFUSION ALARIS NON VENTED BAG ACCESS SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10013361T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that the rn adjusted the blue plastic piece above the door of the channel, when the tubing broke and chemo started spilling.There was no harm to patient.
Event or Problem Description
It was reported that during an infusion of etoposide 200 mg / 500 ml, the rn came to do an flush chemo.The iv tubing tolerated 15ml, but burst at the top of the channel site, releasing fluids on the rn's forehand, channel and hands.Rn was wearing ppe, however; forehead was contaminated.Charge rn was aware and was the bedside with a second nurse and chemo spill kit.The rn affected by the chemo spill washed face for 15 minutes.There was no harm to patient.

• Brand Name: ALARIS NON VENTED BAG ACCESS SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9241609
• Report Number: 9616066-2019-03038
• Device Sequence Number: 13855835
• Product Code: FPA
• UDI-Device Identifier: 10885403223204
• UDI-Public: 10885403223204
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K053049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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: 10013361T
• Device Catalogue Number: 10013361T
• 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: 10/25/2019
• Supplement Report FDA Received Date: 10/28/2019
• 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: 8100, 8015, THERAPY DATE (B)(6) 2019