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

Catalog Number	20350ET
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.3.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¿ texium¿ smartsite¿ low sorbing extension set line detached from the filter.The following information was provided by the initial reporter: "on the extension set the blue line was detach from the white filter.".
Additional Manufacturer Narrative
H6: investigation summary the customer reported the filter detached, and returned photos of the incident.The complaint is verified as a separation at the outlet of the filter.The filter post that connects with glue to the tubing appears to be broken off, so the root cause is broken filter.The root cause cannot be determined.A device history record review could not be performed on material 20350et because the lot number is unknown.
Event or Problem Description
It was reported that the bd alaris¿ texium¿ smartsite¿ low sorbing extension set line detached from the filter.The following information was provided by the initial reporter: "on the extension set the blue line was detach from the white filter.".

• Brand Name: BD ALARIS¿ TEXIUM¿ SMARTSITE¿ LOW SORBING 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16748693
• Report Number: 9616066-2023-00702
• Device Sequence Number: 18299324
• Product Code: FPA
• UDI-Device Identifier: 10885403229756
• UDI-Public: 10885403229756
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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 Catalogue Number: 20350ET
• Device Lot Number: UNKNOWN
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 04/16/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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