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

Catalog Number	MX9059
Medical Device Problem Codes	Material Separation (1562); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
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 extension set with needleless y-site(s) experienced missing component and component separation.The following information was provided by the initial reporter: mx9059: "this one came out of the package with no tubing attached on the port.But others have disconnected at the ports also.".
Additional Manufacturer Narrative
H6: investigation summary the customer reported disconnections straight out of the bag, and returned a photo of the incident.The photo verifies the separation.The root cause is unknown without the physical sample investigation.Device history record review for model mx9059 lot number 22079345 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported that the bd maxguard extension set with needleless y-site(s) experienced missing component and component separation.The following information was provided by the initial reporter: mx9059: "this one came out of the package with no tubing attached on the port.But others have disconnected at the ports also.".

• Brand Name: BD MAXGUARD EXTENSION 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: 16527243
• Report Number: 9616066-2023-00414
• Device Sequence Number: 19487925
• Product Code: FPA
• UDI-Device Identifier: 10885403237584
• UDI-Public: (01)10885403237584
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/15/2023

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: 07/21/2025
• Device Catalogue Number: MX9059
• Device Lot Number: 22079345
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 03/12/2023
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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