MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number 2420-0500

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/16/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one sample was received for quality investigation.The customer complaint of component damage - leak was verified by visual inspection.Evaluation of the infusion set indicated that the tubing separated from the lower male luer connection.Examination of the sample under magnification indicates a lack of solvent on the end of the tubing and within the male luer connection.A device history record review for model 2420-0500, lot number 21063387 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 26jun2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the issue seen in this complaint is a lack of solvent on the tubing and the male luer connection.Investigation of the union location shows a lack of solvent on both the tubing and male luer connection surfaces.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.The root cause for the issue seen in this complaint is a lack of solvent on the tubing and the male luer connection.Investigation of the union location shows a lack of solvent on both the tubing and male luer connection surfaces.A notification has been sent to the manufacturing facility to monitor the occurrence of this issue.

Event Description

It was reported that the bd alaris infusion set experienced device damage while still considered operable.The following information was provided by the initial reporter: i had a primed alaris infusion set at the bedside that was primed only 5 minutes prior to that.I brought the patient in and started an iv and checked the alaris infusion set tubing and it completely broke at the end when i was getting it ready to connect to the patient.It completely broke at the end where the tubing is connected to the end port.Saline came flushing out.I put this tubing aside to send back a product concern report.A new alaris infusion set was used for this patient.

• Brand Name: BD ALARIS INFUSION SET
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12827774
• MDR Text Key: 284809109
• Report Number: 9616066-2021-52434
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012448
• UDI-Public: 37613203012448
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Device Lot Number: 21063387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2021
• 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