MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SECONDARY SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	20350ET
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd alaris secondary set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: called to report that on (b)(6) 2023 they made a chemo taxol bag for a patient at the breast cancer clinic and the filter is leaking.She is not sure if there is a crack around the filter area.Product 20350et extension set w/.2mf, smartsite & texium.Phone (b)(6).
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary the customer reported the filter was leaking, and returned one photo of the sample.The photo verifies the leaking filter.The root cause and exact location of the leak within the filter could not 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 while using bd alaris secondary set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: called to report that on 04/18/23 they made a chemo taxol bag for a patient at the breast cancer clinic and the filter is leaking.She is not sure if there is a crack around the filter area.Product 20350et extension set w/.2mf, smartsite & texium.Phone (b)(6).
Additional Manufacturer Narrative
The following fields were updated, due to additional information: d4.Medical device lot #: 21079233, d4.Medical device expiration date: 30-jul-2024, h4.Device manufacture date: 29-jul-2021.
Event or Problem Description
It was reported, while using bd alaris secondary set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: called to report, that on 04/18/23.They made a chemo taxol bag, for a patient at the (b)(6) clinic and the filter is leaking.She is not sure, if there is a crack around the filter area.Product 20350et, extension set w/.2mf, smartsite & texium.Phone (b)(6).

• Brand Name: BD ALARIS SECONDARY 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: 16916736
• Report Number: 9616066-2023-00877
• Device Sequence Number: 15181028
• Product Code: FPA
• UDI-Device Identifier: 50885403229754
• UDI-Public: (01)50885403229754
• 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,Followup
• Report Date (Section B): 07/28/2023

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: 07/30/2024
• Device Model Number: 20350ET
• Device Catalogue Number: 20350ET
• Device Lot Number: 21079233
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 06/06/2023; 07/12/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/12/2023; 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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