MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ EXTENSION SET, PRESSURE RATED SMARTSITE¿ T-CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20041E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
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 4 of the bd smartsite¿ extension set, pressure rated smartsite¿ t-connector leaked.The following information was provided by the initial reporter: the extension tube leaks when the drug is injected.
Additional Manufacturer Narrative
H6: investigation summary a 20041e sample was not available for investigation; however, the customer indicated the complaint samples were from lots 22025982 and 22025983.The feedback provided by the customer suggests leakage was detected from the extension set during infusion.No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lots 22025982 and 22025983 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 in this instance.Without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported issue.H3 other text : see h10.
Event or Problem Description
It was reported that 4 of the bd smartsite¿ extension set, pressure rated smartsite¿ t-connector leaked.The following information was provided by the initial reporter: the extension tube leaks when the drug is injected.
Event or Problem Description
Additional information provided.The extension tube leaks when the drug is injected.
Additional Manufacturer Narrative
Four 20041e samples were received in opened packaging for investigation; the samples were from lots 22025982 and 22025983.Residual fluid was detected in all samples.The feedback provided by the customer suggests leakage was detected from the extension set during infusion.No further information was available to assist the investigation in this instance.A visual inspection of the returned samples did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience.Functional testing was performed by connecting the returned samples to a 50ml bd plastipak syringe from stock and priming with fluid; no flow issues or leakage was detected throughout testing.The samples were then subjected to pressure testing; again no leakage was detected.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lots 22025982 and 22025983 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects that could have contributed to the customers experience.

• Brand Name: BD SMARTSITE¿ EXTENSION SET, PRESSURE RATED SMARTSITE¿ T-CONNECTOR
• 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: 17338354
• Report Number: 9616066-2023-01471
• Device Sequence Number: 6477792
• Product Code: FPA
• UDI-Device Identifier: 27613203021665
• UDI-Public: (01)27613203021665
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2023

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: 02/25/2025
• Device Catalogue Number: 20041E
• Device Lot Number: 22025983
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 08/10/2023; 10/27/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/28/2023; 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2022
• 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