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

Catalog Number	MX9171
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd extension set 1.2 micron filter leakage occurred from a damaged portion.There was no report of patient impact.The following information was provided by the initial reporter: leaking / breaking.Have five product complaints of this sku and lot number: 23019378.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The customer reported that the extension set was leaking / breaking.One photo was received of material mx9171.The photo shows that extension set was filled with a cloudy white substance, however, the photo does not show leakage from the filter vent.The customer complaint of leakage could not be verified by the visual examination of the photo submitted.A root cause could not be determined because a physical sample was not available for evaluation.A device history record review for material# mx9171 and lot# 23019378 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 31jan2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.Material #: mx9171, batch #: 23019378.It was reported by customer as leaking / breaking.Verbatim: leaking / breaking.Have five product complaints of this sku and lot number 23019378.

• 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: 17888481
• Report Number: 9616066-2023-02014
• Device Sequence Number: 20720833
• Product Code: FPA
• UDI-Device Identifier: 50885403237667
• UDI-Public: (01)50885403237667
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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: 01/31/2026
• Device Catalogue Number: MX9171
• Device Lot Number: 23019378
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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: 9 DA
• Patient Sex: Female