MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S); 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	09/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd bd maxguard administration set with needleless y-site(s) was leaking.The following information was received by the initial reporter with the verbatim: 2 separate sets were defective, first did not have an end cap/port the tubing just ended.The second set of tubing was leaking from one of the ports.Product should have no leaks and have a luer lock male port at one end of tubing.
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported by customer that the infusion set tubing was leaking from one of the ports.No product or photo was returned by the customer.The customer complaint of component damage - 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 mx9968 lot number 23069048 was performed.The search showed that a total of (b)(4) was built on 09jul2023.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.Material #: mx9968.Batch #: 23069048.It was reported by customer that 2 separate sets were defective, first did not have an end cap/port the tubing just ended.The second set of tubing was leaking from one of the ports.Product should have no leaks and have a luer lock male port at one end of tubing.Verbatim: rcc received a complaint via email.Email(s) attached.Medline reference: (b)(4).Item: mx9968.Quantity affected: 2 eaches.Serial/lot number: (b)(6).Po #: (b)(4).Are any samples available for return? yes.Reported issue per customer: productcomplaints@bd.Com.Customer disposition request: credit.Reported issue below: 2 separate sets were defective, first did not have an end cap/port the tubing just ended.The second set of tubing was leaking from one of the ports.Product should have no leaks and have a luer lock male port at one end of tubing.

• Brand Name: BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S)
• 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: 17946809
• Report Number: 9616066-2023-02100
• Device Sequence Number: 7645765
• Product Code: FPA
• UDI-Device Identifier: 50885403237803
• UDI-Public: (01)50885403237803
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/29/2023

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 Expiration Date: 06/09/2026
• Device Catalogue Number: MX9968
• Device Lot Number: 23069048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown