MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S), STOPCOCK(S) AND MANIFOLD; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX4436
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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 with needleless y-site(s), stopcock(s) and manifold was disconnecting the following information was received by the initial reporter with the following verbatim: issue description the iv tubing became disconnected at the stopcock.The opening allowed blood flow to come back up the tubing and onto the floor.This opened up onto the floor and opened a possible source of infection for the patient.This is a frequent problem and happens daily.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
It was reported by customer that the iv tubing became disconnected at the stopcock.No product or photo was returned by the customer.The customer complaint of separation other component - leak could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model mx4436 lot number 24019107 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 08jan2024.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 WITH NEEDLELESS Y-SITE(S), STOPCOCK(S) AND MANIFOLD
• 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: 19762211
• Report Number: 9616066-2024-00994
• Device Sequence Number: 8514417
• Product Code: FPA
• UDI-Device Identifier: 10885403237478
• UDI-Public: (01)10885403237478
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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: MX4436
• Device Lot Number: 24019107
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown