MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXPLUS EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE; INTRAVASCULAR ADMINISTRATION SET

Model Number	MPX9108-C
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd maxplus extension set with needleless connector and y-site the tubing separated from the adaptor.There was no report of patient impact.The following information was provided by the initial reporter: the maxplus tubing (item# mpx9108c) was not bonded together like it should be.
Additional Manufacturer Narrative
Device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: no sample received but photo was provided by the customer.It was reported by the customer that the tubing keeps coming apart unexpectedly.The photos verifies the complaint.The root cause cannot be determined without the physical sample for investigation.A device history record review for model mpx9108-c and lot number 22119057 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.
Event or Problem Description
It was reported while using bd maxplus extension set with needleless connector and y-site the tubing separated from the adaptor.There was no report of patient impact.The following information was provided by the initial reporter: the maxplus tubing (item# (b)(4) was not bonded together like it should be.

• Brand Name: BD MAXPLUS EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE
• 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: 16519725
• Report Number: 9616066-2023-00402
• Device Sequence Number: 14051831
• Product Code: FPA
• UDI-Device Identifier: 50885403274631
• UDI-Public: (01)50885403274631
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/15/2023

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: 11/03/2025
• Device Model Number: MPX9108-C
• Device Catalogue Number: MPX9108-C
• Device Lot Number: 22119057
• 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: 02/15/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• 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