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	MX9433
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for additional lot number is as follows: medical device lot #: 22119051.Medical device expiration date: 07-nov-2025.Device manufacture date: 07-nov-2022.Medical device lot #: 22099088.Medical device expiration date: 05-sep-2025.Device manufacture date: 05-sep-2022.
Event or Problem Description
It was reported that the bd maxguard administration set with needleless y-site(s) experienced tubing coming apart.The following information was provided by the initial reporter: issue: multiple reports of tubing coming apart at port/drip chamber.Two lots have been identified with the issue and have been seen at multiple facilities.So far we have confirmed reports at (b)(6) hospital and (b)(6).Event date: (b)(6) 2023.Ih #: (b)(4).Mfg #: mx9433.Description: set admin iv 130in 15 drop.Sample available : y (if sample is available and would like it sent for your evaluation, please reply all and attach a return shipping label via email) lot #: 22119051 and 22099088.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 13-mar-2023 h.6.Investigation summary: the customer reported separations and returned one used sample.The sample was separated at the inlet of the 1st smart site, and the complaint is verified.Microscope analysis found there to be insufficient solvent applied at the connection.Root cause has been traced to manufacturing issue with solvent application process.The issue is part of a funded project to mitigate the risk of this recurring.Device history record review for model mx9433 lot number 22099088 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 06sep2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Device history record review for model mx9433 lot number 22119051 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10nov2022.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.
Event or Problem Description
It was reported that the bd maxguard administration set with needleless y-site(s) experienced tubing coming apart.The following information was provided by the initial reporter: issue: multiple reports of tubing coming apart at port/drip chamber.Two lots have been identified with the issue and have been seen at multiple facilities.So far we have confirmed reports at park city hospital and st.George.Event date: 2/8/2023 ih #: 32011614 mfg #: mx9433 description: set admin iv 130in 15drop sample available : y (if sample is available and would like it sent for your evaluation, please reply all and attach a return shipping label via email) lot #: 22119051 and 22099088.

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16527245
• Report Number: 9616066-2023-00369
• Device Sequence Number: 16799346
• Product Code: FPA
• UDI-Device Identifier: 10885403237782
• UDI-Public: (01)10885403237782
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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 Catalogue Number: MX9433
• Device Lot Number: SEE H10
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 03/12/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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