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

Catalog Number	MX5301
Medical Device Problem Codes	Disconnection (1171); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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¿ pressure rated extension set with y-site(s) tubing disconnected from the y-site during use, allowing blood to freely flow from the iv site.The following information was provided by the initial reporter: "at the ysite, it disconnected.This allowed blood to flow freely from the iv site and there wasn't a clamp on the portion still attached to the iv site to stop the blood flow.This caused loss of blood and risk of infection to the patient.
Additional Manufacturer Narrative
Investigation summary one photo of was received for quality investigation.The customer complaint of connection issues (disconnection) - flow issues - accuracy (flowing freely) could not be confirmed based on the evaluation of the photo provided.A failure of separation can be confirmed based on the photo provided.A device history record review for model mx5301 lot number 22109038 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that the bd maxguard¿ pressure rated extension set with y-site(s) tubing disconnected from the y-site during use, allowing blood to freely flow from the iv site.The following information was provided by the initial reporter: "at the ysite, it disconnected.This allowed blood to flow freely from the iv site and there wasn't a clamp on the portion still attached to the iv site to stop the blood flow.This caused loss of blood and risk of infection to the patient.

• Brand Name: BD MAXGUARD¿ PRESSURE RATED EXTENSION SET WITH 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17027041
• Report Number: 9616066-2023-01036
• Device Sequence Number: 3455409
• Product Code: FPA
• UDI-Device Identifier: 10885403237553
• UDI-Public: 10885403237553
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/11/2023

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: 10/03/2025
• Device Catalogue Number: MX5301
• Device Lot Number: 22109038
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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