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

Catalog Number	42519E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite gravity set was damaged and leaking.The following information was received by the initial reporter with the verbatim: "we had an issue today with the sub anesthesia tubing from bd.This was being used on a ct patient and was caught right away when fluid started spurting out the back of the manifold and from the split.The tubing split open as you see in the first pic and was also leaking at the back of the manifold.This happened when they were giving sedation and contrast to the patient.The patient was waking and trying to pull things out.The provider said if this was a case where the arms were tucked they would not have known right away that there was an issue.I have asked my techs to pull what we have left of this tubing on the shelves right now.I wasn¿t sure how many are in the store room.I am thinking we may have to find another sub, not sure we can trust this tubing." "i would be available to speak this morning and can be reached at (b)(6).If you are looking to talk about what we need with the 32 cases, then i would be the person to speak with.If you are looking to talk about the product failure, then it would be best to talk to kim richardson or someone from our clinical team that experienced the issue while the product was in use.".
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD ALARIS SMARTSITE GRAVITY 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: 18489909
• Report Number: 9616066-2023-02512
• Device Sequence Number: 11678687
• Product Code: FPA
• UDI-Device Identifier: 37613203010888
• UDI-Public: (01)37613203010888
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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
• Report Date (Section B): 12/27/2023

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: 42519E
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown