MAUDE Adverse Event Report: CAREFUSION SMALLBORE QUADFUSE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10015817
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information requested but not provided.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
It was reported that while putting together tubing for uvc fluids in a sterile field, the nurse noted that the quad fuse had a broken port.The nad would not attach correctly.So before fluid was spiked, a new quad fuse was opened for the nurse and dropped into sterile field.Iv tubing was then able to be attached correctly and fluids were then hung on patient.
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.
Event or Problem Description
It was reported from the pediatric newborn unit that while putting together tubing in a sterile field for uvc fluids to be infused on an infant , the nurse noted that the quad fuse had a micro crack with an uneven surface on the top of one of the ports.The nad would not attach correctly.So before fluid was spiked, a new quad fuse was opened for the nurse and dropped into sterile field.Iv tubing was then able to be attached correctly and fluids were then hung on patient.

• Brand Name: SMALLBORE QUADFUSE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9365119
• Report Number: 9616066-2019-03442
• Device Sequence Number: 14196541
• Product Code: FPA
• UDI-Device Identifier: 10885403234057
• UDI-Public: 10885403234057
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 11/08/2019

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 Expiration Date: 12/10/2021
• Device Model Number: 10015817
• Device Catalogue Number: 10015817
• Device Lot Number: 18125694
• 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: 11/22/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1