MAUDE Adverse Event Report: CFN MEXICO 215 SA DE CV HI-FLOW T-CONN W/LL & 1 VLV PORT; SET, EXTENSION, INTRAVASCULAR

Model Number	20043E
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that hi-flow t-conn w/ll & 1 vlv port leaked.The following information was provided by the initial reporter: i am needing a case number for above mentioned device.When pulled form packaging and primed for patient use, found to be leaking at collar.I have the time and the packaging.Was not actually used in patient care as another item was obtained for use.Date of event is june 8th.
Additional Manufacturer Narrative
It was reported that, the tubing was leaking at the collar.Received from the customer was a used extension set model: 20043e, lot: 20037273.A standalone smarrtsite adapter model: 2000e, lot: unknown was received connected to the female luer of the t-connector set.The as-received set sample was inspected for kinks, holes / tears in the tubing, or damages to the components.There was a crack along the side of the set's female luer lock p/n: 630-01367 component (cavity 8).The crack was observed to be approximately opposite the injection gate on the luer component.The location of the injection gate (below the wings / tabs) indicates that this female luer was manufactured after the change order (co#: 1110016) that moved the injection gate to a lower location to help mitigate and prevent female luer cracks.No tool markings were observed around the observed damaged area.No other damage or issue was observed.Although damage was observed, functional testing was performed.Fluid from a lab syringe was pushed through.The fluid leaked from the crack.No other leak was observed.Equipment used (inspection performed on 2-sep2020): ram optical instrumentation / eq08204 / calibration due date 5-feb-2021.Device history record for model: 20043e, lot: 20037273 shows that the set was manufactured on 28 march 2020 with a total of (b)(4) units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.The customer's report that the tubing was leaking at collar was confirmed.The root cause of the female luer crack was identified to be a result of internal stresses created during the manufacturing process that make it more susceptible to chemical/mechanical attacks and the pvc materials used in the new female luer.
Event or Problem Description
It was reported that hi-flow t-conn w/ll & 1 vlv port leaked.The following information was provided by the initial reporter: i am needing a case number for above mentioned device.When pulled form packaging and primed for patient use, found to be leaking at collar.I have the time and the packaging.Was not actually used in patient care as another item was obtained for use.Date of event is on (b)(6).

• Brand Name: HI-FLOW T-CONN W/LL & 1 VLV PORT
• 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: 10252059
• Report Number: 9616066-2020-02139
• Device Sequence Number: 16332125
• Product Code: FPA
• UDI-Device Identifier: 10885403234873
• UDI-Public: 10885403234873
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• 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: Other
• Device Expiration Date: 03/28/2023
• Device Model Number: 20043E
• Device Catalogue Number: 20043E
• Device Lot Number: 20037273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• 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: 12/07/2020
• 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: 20200608.; 20200608.
• Outcome Attributed to Adverse Event: Other