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

Catalog Number	30207E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 bd alaris smartsite dual-port extension set separated and leaked.The following information was provided by the initial reporter with the verbatim: nursing staff found the extension set disconnected from the line/connection part.This caused leaking & blood flush back from patient.
Additional Manufacturer Narrative
Investigation results: a 30207e sample was not available for investigation; however, the customer indicated the complaint sample was from lot 23029172.The feedback provided by the customer suggests the device separated at the smartsite y-site tubing joint, resulting in leakage.As part of the feedback the customer provided a photograph of their experience.Analysis of the photograph suggests the device separated at the smartsite y-site tubing joint.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 23029172 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported separation.However, the quality team at the manufacturing site has been informed of this complaint in order to be aware of the reported failure mode during future production of this product.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the 30207e product over the past 12 months.
Event or Problem Description
No additional information.

• Brand Name: BD ALARIS SMARTSITE DUAL-PORT EXTENSION 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: 17913488
• Report Number: 9616066-2023-02036
• Device Sequence Number: 18016727
• Product Code: FPA
• UDI-Device Identifier: 37613203011502
• UDI-Public: (01)37613203011502
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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: Health Professional
• Device Expiration Date: 02/09/2026
• Device Catalogue Number: 30207E
• Device Lot Number: 23029172
• 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: 10/03/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• 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