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	MX9128
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxguard administration set with needleless y-site(s) was leaking.The following information was received by the initial reporter with the following verbatim: do you know who i should reach out to regarding the bd maxguard iv tubing? at pesc and psc we are seeing a lot of leaking at the connection site of the tubing and the iv.The tubing does not connect well to the iv.You must, as best as you can, try to overtighten the tubing for it not to come loose.It can be difficult to do because you have to grip the iv tightly and there is not a lot of room to hold onto it.Ref# (b)(4).
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Lot provided 23089203.
Additional Manufacturer Narrative
Sample inv and dhr the customer reported leakage at the male luer connection and returned one unused sample of material mx9128 and lot 23089203.The set was visually examined for defects and abnormalities.No defects or abnormalities were observed.The sample was tested under syringe pressure with a couple different bd connectors in the lab, and no leak was found.The luer was tested with overtightening and, as well as a more lenient connection, and with normal force, the leak still was not replicated.The root cause of this failure could not be identified without a failure investigation.A device history record review could not be performed on material mx9128 because the lot number is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18308029
• Report Number: 9616066-2023-02382
• Device Sequence Number: 15132903
• Product Code: FPA
• UDI-Device Identifier: 50885403237629
• UDI-Public: (01)50885403237629
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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: MX9128
• Device Lot Number: 23089203
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown