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

Catalog Number ME2020

Device Problems Backflow (1064); Defective Component (2292)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

It was reported that bd maxguard extension set was damaged the following information was received by the initial reporter with the following verbatim: the end of the tubing that connects to the patient/mivf tubing (white cap end) broke off while connected to patient, leaving the clear luer lock part in the iv hub and allowing blood to back flow back into the mivf tubing.

Manufacturer Narrative

E1: initial reporter facility name- (b)(6) hospital.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

No additional information was provided.Material#: mme2020, batch number#: 23079080.It was reported by customer that the end of the tubing that connects to the patient/mivf tubing (white cap end) broke off while connected to patient, leaving the clear luer lock part in the iv hub and allowing blood to back flow back into the mivf tubing.Verbatim#: rcc received a complaint via email.Email(s) attached.The end of the tubing that connects to the patient/mivf tubing (white cap end) broke off while connected to patient, leaving the clear luer lock part in the iv hub and allowing blood to back flow back into the mivf tubing.Product#: mme2020.

Manufacturer Narrative

It was reported by customer that the end of the tubing that connects to the patient/mivf tubing (white cap end) broke off while connected to patient, one sample of me2020 was submitted for quality evaluation.Visual examination of the sample submitted shows that the tubing is missing the male luer connector from the extension set.Further examination of the distal end of the tubing shows that there is a lack of solvent at the distal end tubing.The lack of solvent may have contributed to the luer connector separating from the tubing.The customer complaint of separation was confirmed.An additional investigation was then conducted at the manufacturing facility.The investigation at the manufacturing facility indicates that the possible root cause for the issue seen in the complaint is an incorrect method of solvent application (excessive solvent) by the assembler.A quality alert was issued to reinforce the correct solvent application method to avoid the excessive solvent issue in future production.A device history record review for model me2020 lot number 23079080 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12jul2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD MAXGUARD 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18646413
• MDR Text Key: 334795536
• Report Number: 9616066-2024-00180
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403236256
• UDI-Public: (01)20885403236256
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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: ME2020
• Device Lot Number: 23079080
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1