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	08/30/2024
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 leaking the following information was received by the initial reporter with the following verbatim: it was reported by customer that leaking from the filter tubing interface.
Event or Problem Description
Material # mz9270.Batch # 24039216.It was reported by customer that leaking from the filter tubing interface.Rcc received a complaint via email.Leaking from the filter tubing interface.Product number - mz9270.Lot number - 24039216.Additional information received on 05sep: for issue reported under (b)(4): could you please provide a further description of the issue? during infusion, noted filter was leaking.When was this defect observed? during or before use? during use on a patient.What was the impact to the patient? delay of delivery of iv fluids.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No harm.Is there a photo or sample available showing the reported issue? if yes, are you able to provide the address of the facility for us to ship the return label? yes, product and packaging available.Can you please provide an exact date of event in mm-dd-yyyy format? 08-30-2024.
Additional Manufacturer Narrative
The customer reported leaking at filter and distal tubing, and returned 1 sample of material mz9270, lot 24039216.The sample was infused with water, and the leakage was confirmed from the male luer side of filter.The leakage is coming from the tubing connection to filter.The manufacturing site is working on the root cause through a funded project to ensure that the risk of recurrence for the issue is addressed.A quality alert was generated 07nov2024 to communicate the failure and reinforce the correct method of joining the components (tubing/pediatric filter).The issue is a high priority for bd quality.

• 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: 20326144
• Report Number: 9616066-2024-01402
• Device Sequence Number: 12686914
• Product Code: FPA
• UDI-Device Identifier: 10885403240737
• UDI-Public: (01)10885403240737(11)240312(17)270312(10)24039216
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/19/2024

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: MZ9270
• Device Lot Number: 24039216
• 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: 12/19/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown