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

Catalog Number	MP5312-C
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that the bd maxplus¿ pressure rated extension set with needleless connector had flow issues due to the anti-reflux cap blocking fluid during use.The following information was provided by the initial reporter: "anti reflux cap (nc) preventing anything from flowing through connector into extension set it blocks fluid flow".
Additional Manufacturer Narrative
H.6.Investigation summary: two samples (model #mp5312-c) were returned by the customer.It was reported by the customer that anti reflux cap (nc) preventing anything from flowing through connector into extension set it blocks fluid flow.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The samples were connected to a 10 ml bd syringe and attempted to be flushed with water.One sample was able to be flushed.The failure was unable to be replicated in this sample.One sample was unable to be flushed.An occlusion appeared to be connector distal to the maxplus.The sample was further examined under magnification where an occlusion can be seen in the male luer.The customer complaint can be verified in this sample.A quality notification was sent to the manufacturer.Due to an increase in incidents of this failure mode, 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.A device history record review for model mp5312-c lot number 22099463 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 28sep2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that the bd maxplus¿ pressure rated extension set with needleless connector had flow issues due to the anti-reflux cap blocking fluid during use.The following information was provided by the initial reporter: "anti reflux cap (nc) preventing anything from flowing through connector into extension set it blocks fluid flow".

• Brand Name: BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR
• 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: 16670623
• Report Number: 9616066-2023-00625
• Device Sequence Number: 6071388
• Product Code: FPA
• UDI-Device Identifier: 10885403230158
• UDI-Public: 10885403230158
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/11/2023

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: 09/25/2025
• Device Catalogue Number: MP5312-C
• Device Lot Number: 22099463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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