MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD¿ FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S); INTRAVASCULAR ADMINISTRATION SET

Model Number MFS106

Device Problems Deformation Due to Compressive Stress (2889); Improper Flow or Infusion (2954)

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

Event Date 02/07/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the bd maxguard¿ flow controller extension set with needleless y-site(s) tubing had a kink in it that caused flow issues during use.The following information was provided by the initial reporter: "kinked tubing on #mfs106.The kink in the tubing doesn¿t let the fluids flow correctly.".

Manufacturer Narrative

Investigation summary: three samples of material number mfs106 were received for quality investigation.The customer complaint of tubing kinked - flow issues - fluid blockage was verified by inspection.Visual inspection was conducted on the samples submitted and kinks were noticed on the tubing of the outlet of the flow control valve.The flow control valve was then primed and tested for flow accuracy.The flow control valve was set to a flow rate of 250 ml/hr.The test was conducted for 10 minutes.Sample 1 dispensed 32.5 ml in 10 minutes.Sample 2 dispensed 37 ml in 10 minutes.Sample 3 dispensed 37 ml in 10 minutes.All samples showed signs of under infusion.A device history record review for model mfs106 lot number 22069436 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.An investigation was conducted at the manufacturing facility, and it was determined that the kink in the tubing was created by an incorrect coiling direction.The kinking in the tubing is also the cause for the flow issues.

Event Description

It was reported that the bd maxguard¿ flow controller extension set with needleless y-site(s) tubing had a kink in it that caused flow issues during use.The following information was provided by the initial reporter: "kinked tubing on #mfs106.The kink in the tubing doesn¿t let the fluids flow correctly.".

• Brand Name: BD MAXGUARD¿ FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S)
• 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: 16482553
• MDR Text Key: 310814593
• Report Number: 9616066-2023-00314
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403236358
• UDI-Public: 10885403236358
• 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: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MFS106
• Device Catalogue Number: MFS106
• Device Lot Number: 22069436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2022
• 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