MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MICROBORE TRI-FUSE EXTENSION SET, 3 IV.C; 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	11/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: mz9270, batch number#: unknown.It was reported that the bd microbore tri-fuse extension set, 3 iv.C had leakage.The following information was provided by the initial reporter: verbatim#: rcc received a complaint via email.Two 0.2-micron filters noted to be leaking from vent which mitigates infusion of particulate matter - not defective.Product#: mz9270.Additional information provided: 1.Please share the exact date of event in (mm-dd-yyyy) format.11/22/2024 2.Please share the lot number if available.Lot number was not provided only identifier was ref mz9270.3.Please share the captured photo of the event if available.No photo available-product is available for return.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
The customer reported mz9270s were leaking from the vent, and returned two samples, lot unknown.Upon initial visual examination, the sets had no defects or abnormalities.The sets were infused with water from a 10 ml bd syringe, and the complaint of leakage from air vent was verified in 1 sample.The second sample was found to be occluded, and a second investigation was opened for the separate failure.The filter air vent leakage sample failure was communicated to the supplier of the filter, and they confirmed that the root cause is hydrophobicity of the membrane compromised by the drug/ solution entered in contact with the membrane.Essentially, the filter has trouble with infusing certain low surface tension fluids.A dhr review was performed the possible lot, 24039216, based on the laser id (maxzero component) of the sample provided and no qns were found.
Event or Problem Description
No additional information.

• Brand Name: BD MICROBORE TRI-FUSE EXTENSION SET, 3 IV.C
• 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: 21118346
• Report Number: 9616066-2024-02221
• Device Sequence Number: 15643438
• Product Code: FPA
• UDI-Device Identifier: 10885403240737
• UDI-Public: (01)10885403240737
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: Health Professional
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/20/2025
• 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 Age: 3 MO
• Patient Sex: Female