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	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd 32-in std bore set w/ max y conn there were flow issues and blockages.There was no report of patient impact.The following information was provided by the initial reporter: complaint: fluids are not flowing through correctly.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.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 while using bd 32-in std bore set w/ max y conn there were flow issues and blockages.There was no report of patient impact.The following information was provided by the initial reporter: complaint: fluids are not flowing through correctly.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.It was reported by customer that " fluids are not flowing through correctly" could not be verified due to the product not being returned for failure investigation.A device history record review for model mx9175 and lot number 22079350 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.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• 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 ; 8015296192
• MDR Report Key: 15916414
• Report Number: 9616066-2022-01849
• Device Sequence Number: 14569767
• Product Code: FPA
• UDI-Device Identifier: 50885403237674
• UDI-Public: (01)50885403237674
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 01/23/2023

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: 07/19/2025
• Device Model Number: MX9175
• Device Catalogue Number: MX9175
• Device Lot Number: 22079350
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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