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

Catalog Number	DYNDTN1545D
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date of event is unknown; bd awareness date used.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 the bd gravity set had separated.The following information was provided by the initial reporter: we were notified of a complaint from a customer regarding one of your products.Customer report: ¿customer states tubing came disconnected at the manifold.Iv fluids ran out all over the floor and a small amount of blood back flowed to the floor, 1 inch puddle on floor.Iv tubing was put together by another staff member.¿ additional questions have been sent to the customer.Finished good #: dyndtn1545.Finished good lot #: 25125257.Product description: iv admin set,15dr,4nfports, stpcock,109." date reported: 4/16/2026.The customer provided the following additional information: ¿the tubing is set up to free flow, not on a pump.The tubing is coming apart at the connection with the stopcock.¿ customer was unable to provide information regarding the manifold component.

• Brand Name: BD GRAVITY SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25141822
• Report Number: 9616066-2026-01245
• Device Sequence Number: 9378957
• Product Code: FPA
• UDI-Device Identifier: 10080196714933
• UDI-Public: (01)10080196714933
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (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): 05/12/2026

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: DYNDTN1545D
• Device Lot Number: 25125257
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown