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

Catalog Number	42103E-07
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2024
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 smartsite gravity set was separated the following information was received by the initial reporter with the following verbatim: rcc received a complaint via phone.Pir attached.Iv tubing disconnecting at drip chamber as well as at the connection hub at times.Iv's are failing because of the faulty connection.Loose connections pose an infection risk to patients if the system is not a tightly secured system.Product#: 42103e-07 iv tubing¿s are disconnecting at the drip chamber and most recently twice the tubing fell out of the drip chamber while connected to a patient and the iv fluids then spilled out of the bag and required the patient to have the iv tubing changed from their iv.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint that there was a separation could not be verified due to the product not being returned for failure investigation.A device history record review for model 42103e - 07 lot number 23049017 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10apr2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.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.H3 other text : see h10 below.

• 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: 18704705
• Report Number: 9616066-2024-00238
• Device Sequence Number: 15001290
• Product Code: FPA
• UDI-Device Identifier: 50885403225848
• UDI-Public: (01)50885403225848
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 03/15/2024

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 Expiration Date: 04/04/2026
• Device Catalogue Number: 42103E-07
• Device Lot Number: 23049017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown