MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD EXT SET W/MACROBORE 2VPS Y-CONN; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20159E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd ext set w/macrobore 2vps y-conn leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: one of the ports was leaky and had to be clamped shut to prevent back flow of blood.
Additional Manufacturer Narrative
H6: investigation summary: no photo or sample was received for the customer's complaint of leakage.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.A device history record review for model 20159e lot number 22069005 was performed.The search showed that a total of (b)(6) units in 1 lot number was built on 01jun2022.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.H3 other text : see h.10.
Event or Problem Description
It was reported while using bd ext set w/macrobore 2vps y-conn leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: one of the ports was leaky and had to be clamped shut to prevent back flow of blood.

• Brand Name: BD EXT SET W/MACROBORE 2VPS Y-CONN
• 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 ; 8015296192
• MDR Report Key: 15432400
• Report Number: 9616066-2022-01341
• Device Sequence Number: 5845382
• Product Code: FPA
• UDI-Device Identifier: 07613203012270
• UDI-Public: 07613203012270
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/04/2022

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: 06/01/2025
• Device Catalogue Number: 20159E
• Device Lot Number: 22069005
• 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: 08/22/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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