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	MPX5300-C
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxplus¿ pressure rated extension set with needleless connector and y-site broke during use.The following information was provided by the initial reporter: "broke while in use.Date (b)(6) 2023 no harm requiring treatment, just small amount of blood loss.".
Additional Manufacturer Narrative
H.3.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 have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 12-may-2023 h.6.Investigation summary: a complaint of set breaking during use was returned from the customer.Two samples were returned for investigation.One sample had no damages or defects.It was primed with no leakage or occlusion observed.The second sample was separated at the needless connector.Solvent could not be seen on the connector.The lower half of the sample was not returned.Separation was confirmed as the defect.A device history record review for model mpx5300-c lot number 23019150 was performed.The search showed that a total of (b)(4) units in 2 lot numbers were built on (b)(4) 2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect, and a review of the manufacturing process was completed.After review, the potential root cause of separation between the tubing and nac-y component can be related to problems with the mdgn solvent dispenser and the assembler not reporting issues or repairing the dispenser.A quality alert was issued to all involved personnel to ensure the correct tubing handling method while adding solvent, to remind them to check presence of solvent during assembly, and to report any anomalies with the dispenser to the production leader.A quality memo was also issued to reinforce notification and repair of failing solvent dispensers.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd maxplus¿ pressure rated extension set with needleless connector and y-site broke during use.The following information was provided by the initial reporter: "broke while in use.Date on (b)(6) 2023 no harm requiring treatment, just small amount of blood loss.".

• 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: 16934977
• Report Number: 9616066-2023-00903
• Device Sequence Number: 20392217
• Product Code: FPA
• UDI-Device Identifier: 10885403237218
• UDI-Public: 10885403237218
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 08/21/2023

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: 01/10/2026
• Device Catalogue Number: MPX5300-C
• Device Lot Number: 23019150
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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