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	Disconnection (1171); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
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 the bd gravity set had connection issues.The following information was provided by the initial reporter: the complaint is that the connectors are not tight when taken out of the package, so when the clinicians prime iv fluid, it will leak from the connectors, or the connectors will become disconnected completely.So now, the clinicians are having to take extra time checking all the connectors before priming tubing each time.This primarily happens at the yellow 3 way connector.

• 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: 24282909
• Report Number: 9616066-2026-00246
• Device Sequence Number: 13212202
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

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: Health Professional
• Device Catalogue Number: DYNDTN1545D
• Device Lot Number: 25085852
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown