MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. T-CONN W/LL & 1 VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Model Number	20041E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Investigation summary: two used and one new, unopened extension set was received by the customer for investigation.The sets were visually inspected and no defects were observed.All sets were individually functionally tested and no defects were observed.A photo of model connected to the sample for the related complaint was also sent for investigation.A leak at the connection between the two sets were observed and the customer's complaint of a leaky connection was verified.One used primary set was returned as well.The unknown primary set was functionally tested and no defects were observed.The samples of this complaint was tested with the returned samples for the related complaint.The devices were connected using the configuration shown in the photo returned and attached to the returned primary set.The sets were infused at 3 ml/hr and then 30 ml/hr for an hour.Each returned filter extension set, used and unused, was tested with each t-connector extension set, used and unused, and no leakage at any connection was observed.The reported defect could not be replicated.A device history record review for model and lot number was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported t-conn w/ll & 1 vlv port leaked when used.The following information was provided by the initial reporter: "bloomington nicu reports a leaky connection between the bd extension set smallbore tubing and the smartsite extension set.Bloomington nicu reports a leaky connection between the bd extension set smallbore tubing and the smartsite extension set.They did not save the packaging and cannot provide lot numbers, but i do have the tubing.".

• Brand Name: T-CONN W/LL & 1 VLV PORT
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• MDR Report Key: 12264387
• Report Number: 9616066-2021-51685
• Device Sequence Number: 3682641
• Product Code: FPA
• UDI-Device Identifier: 27613203021665
• UDI-Public: 27613203021665
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: 04/10/2024
• Device Model Number: 20041E
• Device Catalogue Number: 20041E
• Device Lot Number: 21045697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 08/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1