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

Catalog Number MP5303-C

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 01/24/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that 2 bd maxplus¿ pressure rated extension set with removable needleless connectors had a loose connection and leaked during use.The following information was provided by the initial reporter: "i had 2 more issues today with the product not tightening and causing leakage.".

Event Description

It was reported that 2 bd maxplus¿ pressure rated extension set with removable needleless connectors had a loose connection and leaked during use.The following information was provided by the initial reporter: "i had 2 more issues today with the product not tightening and causing leakage.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 06-mar-2023.Investigation summary: 2 unused samples for model # mp3503-c were returned for investigation.It was reported by the customer that the product was not tightening and causing leakage.Prior to functional testing the sets were visually examined for defects and abnormalities.No defects or abnormalities were observed.The connection issues could not be seen in the provided samples.The sets were connected to a 10 ml bd syringe filled with water and attempted to be flushed no leakage observed.No issues with connection were observed.The customer complaint could not be replicated.A device history record review for model mp5303-c lot number 22109025 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause could not be determined for this complaint because the issue could not be replicated.A review of the male luer connector has determined that it is constructed within its design parameters.An evaluation of the male luer connectors was conducted to attempt to recreate connection issues and leakage issues, however, no issues could be replicated.

• Brand Name: BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE 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 ; 8015296192
• MDR Report Key: 16390398
• MDR Text Key: 310092944
• Report Number: 9616066-2023-00230
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403236655
• UDI-Public: 10885403236655
• 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,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MP5303-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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