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

Catalog Number	47233E
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ gravity set tubing separated from the chamber and leaked out fluid.The following information was provided by the initial reporter: "tubing came off from priming chamber and is a clean break.Fluid dripped everywhere.".
Additional Manufacturer Narrative
Pr (b)(4).Follow up 1 was inadvertently submitted with h2 left blank.This is a correction that the 1st follow up was done for device evaluation.
Event or Problem Description
No additional information.Mat no.: 47233e.Lot no.: 23029283.It was reported by customer tubing came off from priming chamber and is a clean break.Fluid dripped everywhere.Verbatim: tubing came off from priming chamber and is a clean break.Fluid dripped everywhere.
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr submission for device evaluation.One photo and one sample was received for quality investigation.The customer complaint of separation other component - leak was verified by evaluation of the sample.The sample was further evaluated, and the drip chamber outlet indicates to have a lack of bonding solvent on the surface.A device history record review for model 47233e lot number 23029283 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 17feb2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Investigation of the issue was conducted at the manufacturing facility to determine the root cause of the failure.The findings of the investigation identified an incorrect application of the bonding solvent by the assembler to be the possible root cause.A quality alert was generated to reinforce the correct application of the solvent.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 narrative.
Event or Problem Description
No additional information.Mat no.: (b)(4) lot no.: 23029283 it was reported by customer tubing came off from priming chamber and is a clean break.Fluid dripped everywhere.Verbatim: tubing came off from priming chamber and is a clean break.Fluid dripped everywhere.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16950968
• Report Number: 9616066-2023-00933
• Device Sequence Number: 19736339
• Product Code: FPA
• UDI-Device Identifier: 50885403235441
• UDI-Public: (01)50885403235441
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2023

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 Expiration Date: 02/17/2026
• Device Catalogue Number: 47233E
• Device Lot Number: 23029283
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 10/12/2023; 10/12/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 10/17/2023; 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown