MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX9968
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxguard administration set with needleless y-site was separated the following information was received by the initial reporter with the following verbatim it was reported by customer that tubing fell apart (separation).
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
The customer reported the tubing fell apart, and returned one sample of material mx9968, lot 24049148.Upon initial visual examination, the set was separated at the outlet of the tubing connection on 1st y-site.The complaint was verified.Examination under a microscope found insufficient solvent on the tubing.The manufacturing site found the root cause for the separation at y-site to be related to the solvent assembly process.A quality alert was issued 08nov2024 to communicate and reinforce the failure mode, and prevention through the correct assembly procedure.Device history record review for model mx9968 lot number 24049148 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 09apr2024.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.

• Brand Name: BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE
• 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: 20563302
• Report Number: 9616066-2024-01562
• Device Sequence Number: 15278192
• Product Code: FPA
• UDI-Device Identifier: 10885403237805
• UDI-Public: (01)10885403237805(11)240406(17)270406(10)24049148
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 12/10/2024

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: MX9968
• Device Lot Number: 24049148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown