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

Device Problems Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2023

Event Type  malfunction  

Event Description

It was reported that 4 of the bd maxplus¿ pressure rated extension set with needleless connector had a loose connection.The following information was provided by the initial reporter: it appears the blue hub is attached at an angle/insecurely rather than securely.

Manufacturer Narrative

H.6 investigation summary: a complaint of male luer being assembled at an angle and insecurely was received from the customer.No product or photo was returned by the customer.The customer complaint of loose component - leak and flow issues could not be verified due to the product not being returned for failure investigation.A device history record review for model mp5312-c lot number 22129095 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 08dec2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR
• Type of Device: 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: 16913742
• MDR Text Key: 315279550
• Report Number: 9616066-2023-00870
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230158
• UDI-Public: (01)10885403230158
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MP5312-C
• Device Lot Number: 22129095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1