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 Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 extension tubing leaked at the injection port.
Additional Manufacturer Narrative
Additional information provided: d.10 & d.11.The customer's report that the extension tubing leaked at the injection port was not confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted a tear in the primary set's silicone segment directly below the upper fitment component.No other damage or issue was observed.Functional testing confirmed leaking from the tear.Pressure testing resulted in no leaking.The root cause was not identified.
Event or Problem Description
It was reported that the extension tubing sets leaked at the injection port.Although requested, there has been no impact to patient response or additional event information made available to date.Note: we have been having trouble with some extension tubing leaking at the injection ports.The product is maxguard extension set with 2 needleless y-sites mx9059.I have 2 used tubing sets here and one that is likely to be from the same lot (19075824).I don¿t know if you want these or not, but we thought you¿d like to know.Our or/pacu is the only unit that uses this particular product.

• 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: 9373451
• Report Number: 9616066-2019-03471
• Device Sequence Number: 11440292
• Product Code: FPA
• UDI-Device Identifier: 10885403237584
• UDI-Public: 10885403237584
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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: MX9059
• Device Catalogue Number: MX9059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 02/27/2020
• 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: (2)CUROS CAPS, THERAPY DATE UNK