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

Catalog Number	ME2010
Medical Device Problem Codes	Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E4.The initial reporter also notified the fda may, 2024.Medwatch report # (b)(4).H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd maxguard extension set had flow issues the following information was received by the initial reporter with the following verbatim: iv octreotide was being set up to infuse via mini infuser.Syringe connected to iv tubing, and was infusing by itself via gravity without mini infuser plunger moving.Mini infuser tubing should not be able to infuse by gravity.As a result, the patient received the drug as a bolus instead of the ordered rate over 30 minutes.Model# me2010.Lot# 23049147.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint that there is a blockage could not be verified due to the product not being returned for failure investigation.A device history record review for model me2010 lot number 23049147 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13apr2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
No additional info.

• Brand Name: BD MAXGUARD EXTENSION SET
• Common Device Name: 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: 19696379
• Report Number: 9616066-2024-00961
• Device Sequence Number: 8066571
• Product Code: FPA
• UDI-Device Identifier: 10885403236235
• UDI-Public: (01)10885403236235
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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
• Operator of Device: Other
• Device Catalogue Number: ME2010
• Device Lot Number: 23049147
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male