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

Catalog Number	10794983
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 alaris extension set was damaged.The following information was received by the initial reporter with the following verbatim.It was reported by customer that quadfuse infusing vasopressors, sedation, and ionotropic agents, cracked, patient experienced hemodynamic instability and immediate intervention was required.
Additional Manufacturer Narrative
Investigation summary: one sample was received and analyzed by our quality team with the customer's complaint of damaged/ leaking female luer.The 4 way microbore set was visually examined and the complaint was verified as the crack was barely visible to naked eye.Saline was injected using a 10ml syringe through the cracked female luer and the solution sprayed out from crack.The root cause of this issue is unknown, but after further analysis under a high power digital microscope- the crack resembles that of female luer cracks that were created by over tightening male luer connector.This is a possible root cause.A device history record review could not be performed because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
Sample received.

• Brand Name: BD ALARIS 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: 22030787
• Report Number: 9616066-2025-01248
• Device Sequence Number: 8492812
• Product Code: FPA
• UDI-Device Identifier: 10885403234293
• UDI-Public: (01)10885403234293
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 08/26/2025

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: 10794983
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown