MAUDE Adverse Event Report: CFN MEXICO 215 SA DE CV TRI-PORT EXT W/3 VLV PORTS; SET, EXTENSION, INTRAVASCULAR

Model Number	20038E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that tri-port ext w/3 vlv ports cracked and leaked on 5 occasions.The following information was provided by the initial reporter: material #: unknown, batch #: unknown.It was reported neck that spins at the male end of the trifuse have cracked/leaked about 5 different times.Our nurses are seeing many of the trifuses cracking at the part that attaches the trifuse to the iv tubing or iv hub.The part i am referring to is the neck that spins at the male end of the trifuse.They are noticing leaking and cracking at this junction.
Additional Manufacturer Narrative
It was reported neck that spins at the male end of the trifuse have cracked/leaked about 5 different times.Received from the customer are 5 tri-port extension sets model 20038e lot unknown.All sets were received with green disinfecting alcohol caps.Also received is one used 4-way stopcock and one used non-bd microclave.The sets were visually inspected for cracks, misassemblies or damages to the components.Visual inspection found on all received sets that the male luer (p/n 630-02698) collar was cracked or broken.Closer inspection under a lab microscope observed no tool marks at the break site of the male luer collar.No further testing was performed due to the obvious leaking that would occur.Equipment used for testing on (b)(6) 2020: optical ram-cnc, eq 08204, 5-feb-21.Device history record for model 20038e could not be performed due to no lot number being provided by customer.The customer¿s reports that the male end of the trifuse have cracked/leaked was confirmed on all five received sets.The root cause of the crakcs and breaks could not be definitively determined.Previous investigations have shown that stress and cracks may result from overtightening on the male luer.In addition, previous similar investigations have found that if the application of alcohol was not allowed proper time to dry when mating components, it could create a bond resulting in difficulties during disconnection.H3 other text : see h10.
Event or Problem Description
It was reported that tri-port ext w/3 vlv ports cracked and leaked on 5 occasions.The following information was provided by the initial reporter: material #: unknown, batch #: unknown.It was reported neck that spins at the male end of the trifuse have cracked/leaked about 5 different times.Our nurses are seeing many of the trifuses cracking at the part that attaches the trifuse to the iv tubing or iv hub.The part i am referring to is the neck that spins at the male end of the trifuse.They are noticing leaking and cracking at this junction.

• Brand Name: TRI-PORT EXT W/3 VLV PORTS
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CFN MEXICO 215 SA DE CV; parque industrial el florido.; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10251974
• Report Number: 9616066-2020-02133
• Device Sequence Number: 596749
• Product Code: FPA
• UDI-Device Identifier: 07613203011976
• UDI-Public: 7613203011976
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2020

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: 20038E
• Device Catalogue Number: 20038E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 09/14/2020
• 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: 20200617; 20200617
• Outcome Attributed to Adverse Event: Other