MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMARTSITE¿ BAG SPIKE, PRIMING VOLUME 0.5 ML; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2300E-0500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the smartsite¿ bag spike, priming volume 0.5 ml damaged, breaking.2 of 2 related files.The following information was provided by the initial reporter: some are also breaking.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Followup mdr submission for device evaluation: no product or photo was returned by the customer.The customer complaint that there was leakage could not be verified due to the product not being returned for failure investigation.A device history record review for model 2300e-0500 lot number 23065151 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 24jun2023.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.
Event or Problem Description
No additional information it was reported that the smartsite¿ bag spike, priming volume 0.5 ml damaged, breaking.2 of 2 related files.The following information was provided by the initial reporter: some are also breaking.

• Brand Name: SMARTSITE¿ BAG SPIKE, PRIMING VOLUME 0.5 ML
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17896048
• Report Number: 9616066-2023-02011
• Device Sequence Number: 14294443
• Product Code: FPA
• UDI-Device Identifier: 20885403235020
• UDI-Public: (01)20885403235020
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K970485
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: 06/16/2026
• Device Catalogue Number: 2300E-0500
• Device Lot Number: 23065151
• 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: 09/20/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• 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