MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ SMARTSITE¿ LOW SORBING EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number G30454V

Device Problem Leak/Splash (1354)

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

Event Date 12/04/2021

Event Type  malfunction  

Event Description

It was reported that the bd alaris¿ smartsite¿ low sorbing extension set was leaking chemotherapy drugs at the iv tubing connection site.There was no patient impact.The following information was provided by the initial reporter: "using the alaris 9002tig01-g infusion pump with the low sorbing (tpe) extension set with the clamps for oncology, there has been leaks coming from the junction of the tubing at the connector at the very end where the set connects with an iv line.It is leaking chemotherapy drugs!".

Manufacturer Narrative

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.

Manufacturer Narrative

Correction: after further evaluation of the complaint, it has been determined that the previously submitted mfr report# 9616066-2021-52660 was sent in error.This device is manufactured in a facility that does not manufacture devices for the us market.These devices are sold outside of the us and are not similar to bd devices registered or sold in the us.Therefore, this is exempt from from us fda reporting requirements.H3 other text : see h10.

Event Description

It was reported that the bd alaris¿ smartsite¿ low sorbing extension set was leaking chemotherapy drugs at the iv tubing connection site.There was no patient impact.The following information was provided by the initial reporter: "using the alaris 9002tig01-g infusion pump with the low sorbing (tpe) extension set with the clamps for oncology, there has been leaks coming from the junction of the tubing at the connector at the very end where the set connects with an iv line.It is leaking chemotherapy drugs!".

• Brand Name: BD ALARIS¿ SMARTSITE¿ LOW SORBING EXTENSION 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: 13120279
• MDR Text Key: 285616782
• Report Number: 9616066-2021-52660
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

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: Health Professional
• Device Catalogue Number: G30454V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/28/2022
• Supplement Dates FDA Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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