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 Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Investigation summary: a 20041e product was not available for investigation; however the customer confirmed that the complaint sample was from lot 21016092.The connecting products used were also not available for investigation.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21016092 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined in this instance.Without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported issue.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the 20041e product.
Event or Problem Description
It was reported that 2 t-conn w/ll & 1 vlv port sets had occluded flow during use.The following information was provided by the initial reporter: "flow occlusion".
Additional Manufacturer Narrative
H6: investigation summary: a 20041e product was not available for investigation; however the customer confirmed that the complaint sample was from lot 21016092.The connecting products used were also not available for investigation.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21016092 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the 20041e product.
Event or Problem Description
It was reported that 2 t-conn w/ll & 1 vlv port sets had occluded flow during use.The following information was provided by the initial reporter: "flow occlusion".

• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12264330
• Report Number: 9616066-2021-51681
• Device Sequence Number: 3682053
• Product Code: FPA
• UDI-Device Identifier: 27613203021665
• UDI-Public: 27613203021665
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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: 01/20/2024
• Device Model Number: 20041E
• Device Catalogue Number: 20041E
• Device Lot Number: 21016092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown