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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4 device expiration date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris smartsite dual-port extension set was damaged, break causing leakage.The following information was provided by the initial reporter: it was reported that incident occurred post operation.Extension set connected to cvc.Extension set fall apart with no tension on line.Break occurred at junction of line and side arm.Observed blood leaking out of broken port line.Potential blood loss or air embolus.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Lot number information provided and updated since initial submission.Investigation results: a 30207e product was not available for investigation; however the customer confirmed that one of the complaint samples was from lot 23029172 and the other was from an unknown lot.The customer indicates that on two occasions, the tubing separated from the y-port during use, leading to leakage.As part of the investigation, the customer provided a photograph of the affected samples; analysis of the photographs confirmed the customer's experience with the tubing identified to have separated from the y-port in each instance.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.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17916329
• Report Number: 9616066-2023-02044
• Device Sequence Number: 2983018
• Product Code: FPA
• UDI-Device Identifier: 07613203011495
• UDI-Public: 07613203011495
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022209
• 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
• 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: Other
• 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: 09/27/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• 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