MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ9270
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2024
Type of Reportable Event	Malfunction
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
It was reported that bd maxzero multi-fuse extension set with needleless connector was damaged the following information was received by the initial reporter with the following verbatim (b)(6) 2024 during infusion, started leaking from the hole on the back of the filter.
Additional Manufacturer Narrative
It was reported by customer the product started leaking from the hole on the back of the filter.One sample of mz9270 was submitted for quality evaluation.Visual examination of the infusion set was conducted and no damages or abnormalities.The extension set was then tested for leaks by priming the set with a solution of glycerin and water and conducting a simulated infusion through the extension set at a rate of 1 ml/hr.Bubbles were immediately indicated coming from the filter vent.The customer complaint of leakage was confirmed.The investigation was forwarded to the supplier for further evaluation.Due to the details of the failure not being specific, the supplier could not determine the root cause to be a manufacturing issue or a user issue.The root cause for the failure could not be determined.A device history record review for model mz9270 lot number unknown was performed.The search showed that a total of (b)(4) units in 1 lot number was built on12mar2024.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
Material # mz9270 batch # unknown.It was reported by customer that (b)(6) 2024 during infusion, started leaking from the hole on the back of the filter.Verbatim: rcc received a complaint via email.Email(s) attached.(b)(6) 2024 during infusion, started leaking from the hole on the back of the filter.Product number - mz9270.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
• 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: 20323663
• Report Number: 9616066-2024-01400
• Device Sequence Number: 7678905
• Product Code: FPA
• UDI-Device Identifier: 10885403240737
• UDI-Public: (01)10885403240737
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• 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): 01/23/2025

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: MZ9270
• Device Lot Number: UNKNOWN
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 01/23/2025
• 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