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

Catalog Number	MPX5302-C
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 bd maxplus¿ pressure rated extension sets with needleless connector and y-site had clogged tubing during use.The following information was provided by the initial reporter: "fluid does not flow through tubing.Has happened at least two times with different staff with the same lot.".
Additional Manufacturer Narrative
Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 06-oct-2022.H6: investigation summary: one sample model mpx5302-c was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.A 10 ml bd syringe filled with water was attached to the set and the set was attempted to be primed.The set was unable to be primed.Upon closer visual inspection under a microscope, excess solvent was seen near the female luer.A device history record review for model mpx5302-c lot number 22069498 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A trend for this occlusion issue has been identified for this product line.A capa (corrective action preventative action) has been initiated, and a team has been assembled in order to investigate the issue.
Event or Problem Description
It was reported that 2 bd maxplus¿ pressure rated extension sets with needleless connector and y-site had clogged tubing during use.The following information was provided by the initial reporter: "fluid does not flow through tubing.Has happened at least two times with different staff with the same lot.".

• Brand Name: BD MAXPLUS¿ PRESSURE RATED 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 ; 8015296192
• MDR Report Key: 15663327
• Report Number: 9616066-2022-01599
• Device Sequence Number: 17766981
• Product Code: FPA
• UDI-Device Identifier: 10885403237232
• UDI-Public: (01)10885403237232
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/22/2023

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 Catalogue Number: MPX5302-C
• Device Lot Number: 22069498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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