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	MX9433
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
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.
Event or Problem Description
It was reported that the bd maxguard¿ administration set with needleless y-site had no end on the tubing to connect it to the iv.The following information was provided by the initial reporter: "d iv tubing was flawed.On opening iv tubing it was noted that there was no end on the tubing to connect it to the iv start tubing that would be used on the pt.New tubing set was obtained to attach to iv bag.Pt not aware that there was any issue with the iv tubing and not involved because it was discovered before the iv was started.Was there only one occurrence of this issue? yes.So far we have only heard of it happening once.Was there any patient harm or adverse or adverse events? no patient harm.Issue was discovered before it ever reached a patient.".
Event or Problem Description
It was reported that the bd maxguard¿ administration set with needleless y-site had no end on the tubing to connect it to the iv.The following information was provided by the initial reporter: "d iv tubing was flawed.On opening iv tubing it was noted that there was no end on the tubing to connect it to the iv start tubing that would be used on the pt.New tubing set was obtained to attach to iv bag.Pt not aware that there was any issue with the iv tubing and not involved because it was discovered before the iv was started.Was there only one occurrence of this issue? yes ¿ so far we have only heard of it happening once.Was there any patient harm or adverse or adverse events? no patient harm.Issue was discovered before it ever reached a patient.".
Additional Manufacturer Narrative
Investigation summary: one sample was received for quality investigation.The customer complaint of misassembly was verified by visual inspection.Evaluation of the sample submitted shows that the distal connection of the extension set is missing from the assembly.A device history record review for model mx9433 lot number 22129074 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the missing connection is a failure at the manufacturing facility to construct the assembly correctly.The manufacturing location has conducted an investigation into the issue and it was determined that the root cause for the issue was due to the technician not assembling the infusion set correctly.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16920263
• Report Number: 9616066-2023-00879
• Device Sequence Number: 12495256
• Product Code: FPA
• UDI-Device Identifier: 10885403237782
• UDI-Public: 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): 06/12/2023

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 Expiration Date: 12/06/2025
• Device Catalogue Number: MX9433
• Device Lot Number: 22129074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2022
• 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