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

Device Problem Component Missing (2306)

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

Event Date 09/23/2023

Event Type  malfunction  

Event Description

It was reported by bd maxguard administration set with needleless y-site(s) that end cap was missing.The following information was received by the initial reporter with the verbatim: 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.

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.

Manufacturer Narrative

It was reported by customer that the infusion set did not have an end cap/port the tubing just ended.No product or photo was returned by the customer.The customer complaint of misassembly 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) units in 1 lot number 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.H3 other text : see narrative below.

Event 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: (b)(4).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)
• 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: 17919446
• MDR Text Key: 325593084
• Report Number: 9616066-2023-02061
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403237803
• UDI-Public: (01)50885403237803
• 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: 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
• Device Operator: Other
• Device Catalogue Number: MX9968
• Device Lot Number: 23069048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1