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

Catalog Number	25202E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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 extension set was loose.The following information was received by the initial reporter with the following verbatim material #25202e, lot #25029340.It was reported by customer that the extension tubing coming loose.
Additional Manufacturer Narrative
Investigation summary: one photo was received and analyzed by our quality team with the customer's complaint of connection issues.The photo does not show the affected component for further investigation.A device history record review was performed and there was a quality notification that detailed a stopcock issue for this lot that is a potential root cause of this failure.The complaint has been verified but the exact root cause is unknown.

• Brand Name: BD EXTENSION SET
• 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: 22206826
• Report Number: 9616066-2025-01576
• Device Sequence Number: 7723640
• Product Code: FPA
• UDI-Device Identifier: 10885403235146
• UDI-Public: (01)10885403235146
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 09/10/2025

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: Other
• Device Catalogue Number: 25202E
• Device Lot Number: 25029340
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown