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

Catalog Number	47177E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
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 alaris smartsite gravity set had leakage.The following information was provided by the initial reporter: gravity set 47177e, issues in radiology with leaking at distal end of fixed collar when connecting to mating component (catheter adaptor).Issue may be due to opening vent when filling drip chamber with glass bottle.They had a mating issue also with a specialized catheter/foley device in cysto, which resulted in them having to cancel the case.We do not have a sample of the foley, issue was also leaking at distal end.

• Brand Name: BD ALARIS SMARTSITE 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: 25494385
• Report Number: 9616066-2026-01556
• Device Sequence Number: 18645233
• Product Code: FPA
• UDI-Device Identifier: 10885403235436
• UDI-Public: (01)10885403235436(11)260128(17)290127(10)26015673
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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: 47177E
• Device Lot Number: 26015673
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown