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

Catalog Number 2420-0007

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 01/17/2023

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.Device evaluated by mfr: 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 the bd alaris¿ pump module smartsite¿ infusion set tubing had a small hole in it that caused leakage during use.The following information was provided by the initial reporter: "alaris tubing was leaking and found a small hole near the blue connector that sits at the top of the alaris tubing.".

Manufacturer Narrative

A complaint of a hole in the tubing causing leakage was received from the customer.No product or photo was returned by the customer.The customer complaint of tubing defective/ damaged and leakage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2420-0007 because the lot number is unknown.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

Event Description

No additional information.

• Brand Name: BD ALARIS¿ PUMP MODULE SMARTSITE¿ 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16317610
• MDR Text Key: 309057007
• Report Number: 9616066-2023-00149
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 07613203021012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• 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: 07/18/2024

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
• Device Operator: Other
• Device Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 07/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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