MAUDE Adverse Event Report: CAREFUSION 36 IN STANDBORE SET W/2 MAX Y CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MX9059
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 discarded and not returned for failure investigation.The root cause of this failure was not identified.Sections were requested but not provided.
Event or Problem Description
It was reported that the extension tubing set nac-y needle-free valve leaked during a blood transfusion.When the (b)(6) alcohol cap was removed from the needle-free valve, the entire alcohol pad inside of the (b)(6) alcohol cap was saturated with blood.It was noted that the patient had a chest port that had not been utilized and the leak was not immediately identified under the patient' shirt.The tubing set was replaced.The patient had to have a paper shirt provided to him to go home in.There were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
Correction: d.1 & d.4.The customer's report that the extension tubing set nac-y needle-free valve leaked was not confirmed.The set samples were visually inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection of the set noted no damage or any anomalies.Functional and pressure testing resulted in no leaks, alarms or issues.The root cause was not identified.
Event or Problem Description
It was reported from the infusion center that the extension tubing set nac-y needle-free valve leaked during a blood transfusion.When the the curos alcohol cap was removed from the needle-free valve, the entire alcohol pad inside of the curos alcohol cap was saturated with blood.It was noted that the patient had a chest port that had not been utilized and the leak was not immediately identified under the patient' shirt.The tubing set was replaced.There were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
Correction on initial report: b.5 & d.4 2 photos provided by the customer shows 1)unopened extension set model mpx5302-c with texts "leak." pointing to nac y and male luer components and 2)unopened maxplus connector with text "our interim solution to the leaks will be to insert the iv with the above adapter so that the iv/opsite are not compromised if the extension tubing fails".The root cause was not identified.
Event or Problem Description
It was reported from the infusion center that the extension tubing set nac-y needle-free valve leaked during a blood transfusion.When the the curos alcohol cap was removed from the needle-free valve, the entire alcohol pad inside of the curos alcohol cap was saturated with blood.It was noted that the patient had a chest port that had not been utilized and the leak was not immediately identified under the patient' shirt.The tubing set was replaced.There were no adverse effects caused to the patient from the event.
Event or Problem Description
It was reported from the infusion center that the extension tubing set nac-y needle-free valve leaked during a blood transfusion.When the the curos alcohol cap was removed from the needle-free valve, the entire alcohol pad inside of the curos alcohol cap was saturated with blood.It was noted that the patient had a chest port that had not been utilized and the leak was not immediately identified under the patient' shirt.The tubing set was replaced.There were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
Additional information provided: d.10.*****************************************.

• Brand Name: 36 IN STANDBORE SET W/2 MAX Y CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9746068
• Report Number: 9616066-2020-00451
• Device Sequence Number: 1814693
• Product Code: FPA
• UDI-Device Identifier: 10885403237225
• UDI-Public: 10885403237225
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/27/2020

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: MX9059
• Device Catalogue Number: MX9059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 03/14/2020; 04/09/2020; 04/21/2020
• 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: 2426-0007.; PRI TUBING,CHEST PORT, THERAPY DATE UNK.