MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD 32-IN STD BORE SET W/ MAX Y CONN; INTRAVASCULAR ADMINISTRATION SET

Model Number	MX9175
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd 32-in std bore set w/ max y conn clogged.The following information was provided by the initial reporter: they are primed prior to using on a patient.The fluid will flow through our primary line but will not flow when the extension is put on.Multiple nurses tried un-attaching and reattaching with no flow obtained.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary no sample was received so no investigation performed for reported failure mode.A device history record review for model mx9175 and lot number 22099394 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.H3 other text : see h10.
Event or Problem Description
It was reported that the bd 32-in std bore set w/ max y conn clogged.The following information was provided by the initial reporter: they are primed prior to using on a patient.The fluid will flow through our primary line but will not flow when the extension is put on.Multiple nurses tried un-attaching and reattaching with no flow obtained.

• Brand Name: BD 32-IN STD BORE SET W/ MAX Y CONN
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16569845
• Report Number: 9616066-2023-00486
• Device Sequence Number: 5895908
• Product Code: FPA
• UDI-Device Identifier: 50885403237674
• UDI-Public: (01)50885403237674
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: 09/20/2025
• Device Model Number: MX9175
• Device Catalogue Number: MX9175
• Device Lot Number: 22099394
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/18/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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