MAUDE Adverse Event Report: BECTON DICKINSON MICROBORE TRI-FUSE EXTENSION SET, 3 IV.C; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MZ9270
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: mz9270 batch#: unknown.It was reported by the customer that we had an incident where tpn filter was leaking.No harm, but nurse had to break into sterile lane and change product, and a leak/opening in line could introduce bacteria and potentially put patient at risk for a bloodstream infection.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material#: mz9270, batch#: 24039216.It was reported by the customer that we had an incident where tpn filter was leaking.Verbatim: we had an incident where tpn filter was leaking.I have sample available to send it to you.Please advise next process.I have cc'd nurse educator to this email if you have any clinical questions.Additional info: 1.The defect was observed during use on a patient.2.No, but nurse had to break into sterile lane and change product, and a leak/opening in line could introduce bacteria and potentially put patient at risk for a bloodstream infection.3.(b)(6) 2024.5.There has been lots of issues within the past year with our tpn filters, but i believe since the most recent product change (b)(6) 2024) - this is the second occurrence 6.No.
Additional Manufacturer Narrative
It was reported that the filter was leaking.One sample model mz9270, lot 24039216 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The sample was primed with water, but the filter membrane was not filtering out air.The sample was flushed, the membrane was dried, and the hydrophobicity of the membrane was restored.The reason for the membrane leaking is that the hydrophobicity of the membrane must have been compromised during use and not during the manufacturing process.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: MICROBORE TRI-FUSE EXTENSION SET, 3 IV.C
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 20902320
• Report Number: 9616066-2024-02031
• Device Sequence Number: 9032479
• Product Code: FPA
• UDI-Device Identifier: 10885403240737
• UDI-Public: (01)10885403240737
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: 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: 12/02/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/22/2025
• 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 Sex: Unknown