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	Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 22109034.Medical device expiration date: 03-oct-2025.Device manufacture date: 03-oct-2022.Medical device lot #: 22109036.Medical device expiration date: 03-oct-2025.Device manufacture date: 03-oct-2022.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd maxplus¿ pressure rated extension set with needleless connector and y-site there was component separation.There was no report of patient impact.The following information was provided by the initial reporter: the extension set is blowing apart where the tubing meets the connectors.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 14-mar-2023.Investigation summary: the customer reported the tubing is blowing apart at the connector, and returned one used sample of lot 22109034, and 3 unopened ones.There were also 3 unopened samples of lot 22109036.There were 7 total samples and all were material mpx5302-c.The used sample verifies the complaint, and was separated at the inlet of smart site.The remaining 6 unopened samples were tested for separation, and none was found.The root cause for the failure was traced to manufacturing solvent assembly process.Quality alert was issued to the assemblers to address the issue.Device history record review for model mpx5302-c lot number 22109036 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Device history record review for model mpx5302-c lot number 22109034 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported while using bd maxplus¿ pressure rated extension set with needleless connector and y-site there was component separation.There was no report of patient impact.The following information was provided by the initial reporter: the extension set is blowing apart where the tubing meets the connectors.

• 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 ; 8448235433
• MDR Report Key: 16612602
• Report Number: 9616066-2023-00553
• Device Sequence Number: 6149373
• Product Code: FPA
• UDI-Device Identifier: 10885403237232
• UDI-Public: 10885403237232
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/31/2023

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: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (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