MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD EXTENSION SET 1.2 MICRON FILTER; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	ME1225
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.2.Patient¿s birthday was not provided, (b)(6) 2008 was used based on age of patient.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd extension set 1.2 micron filter the device was damaged and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: just wanted to updated everyone on this event that just occurred in the nicu with the 1.2 micron lipid filter me1225.The lipids were leaking from the circular area on the back side of the filter.Once we replaced the filter, i was able to flush freely through the filter.A new filter connector was replaced.One of the nurses in med-surg had this same problem with the me1225 (extension set with 1.2 micron filter) as well.They pulled another and had no issues.They also saved it, and i am having the same issue.
Event or Problem Description
No additional info.
Additional Manufacturer Narrative
The customer reported that lipids were leaking from the filter vent.One photo was taken by the customer but does not verify the leakage.No sample was returned.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model me1225 lot number 23029211 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13feb2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD EXTENSION SET 1.2 MICRON FILTER
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17925576
• Report Number: 9616066-2023-02070
• Device Sequence Number: 20534106
• Product Code: FPA
• UDI-Device Identifier: 10885403236129
• UDI-Public: (01)10885403236129
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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 Expiration Date: 02/13/2026
• Device Catalogue Number: ME1225
• Device Lot Number: 23029211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Male