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
Medical Device Problem Codes	Backflow (1064); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 bd maxguard administration set with needleless y-site(s) separated while in use causing leakage and back flow of blood with the iv.It was reported by the initial reporter that verbatim: per nurse she just started a client's iv and went to draw up her nutrients.When i came back and started iv pushing her nutrients through the port closest to the iv fluids, the tubing completely snapped in half and ivf were flowing everywhere on the ground and the client's iv started back flowing blood immediately.It made a mess and was very inconvenient for the client.Medline reference: (b)(6).Item: mx9968.Quantity affected: 1 case.Serial/lot number: (b)(6).Po #: (b)(6).
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: 11-sep-2023.H.6.Investigation summary: the customer reported the tubing snapped and leaked, and returned 34 samples.The samples were pull tested for separation issues, and only a few samples verified the complaint.Device history record review for model mx9968 lot number 23049167 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 17apr2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Root cause traced to insufficient solvent.The manufacturing facility issued a quality notification to personnel on 5jun2023 to notify personnel to conduct periodic reviews of the solvent dispenser.This will lower the risk of solvent based separations in the tubing sets.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 bd maxguard administration set with needleless y-site(s) separated while in use causing leakage and back flow of blood with the iv.It was reported by the initial reporter that verbatim: per nurse she just started a client's iv and went to draw up her nutrients.When i came back and started iv pushing her nutrients through the port closest to the iv fluids, the tubing completely snapped in half and ivf were flowing everywhere on the ground and the client's iv started back flowing blood immediately.It made a mess and was very inconvenient for the client.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17484121
• Report Number: 9616066-2023-01689
• Device Sequence Number: 12604256
• Product Code: FPA
• UDI-Device Identifier: 10885403237805
• UDI-Public: (01)10885403237805
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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 Catalogue Number: MX9968
• Device Lot Number: 23049167
• 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: 07/28/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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