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

Model Number	20159E
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two bd alaris smartsite extension set were defective.The following information was provided by the initial reporter: it was reported by the customer that the product are defective.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for additional lot number is as follows: medical device lot #: 22029775.Medical device expiration date: 2025-02-17.Device manufacture date: 2022-02-17.
Event or Problem Description
It was reported that two bd alaris smartsite extension set were defective.The following information was provided by the initial reporter: it was reported by the customer that the product are defective.
Additional Manufacturer Narrative
H6: investigation summary: a complaint of defective sets was received from the customer.75 unopened samples of lot 22029775 were received for investigation.Through visual inspection, the customer complaint was confirmed.All 75 samples had opaque colored tubing at the connector of the two y-sites.There also seemed to be visible solvent at the edges.6 samples also had kinks in the tubing above the connector.29 samples were also dirty with some clear/ white colored substance in different parts of the set.14 sets were tested for flow issues and 6 of these occluded.Two lot numbers were received from the customer.A device history record review for model 20159e lot number 21119807 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 05nov2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 20159e lot number 22029775 was performed.The search showed that a total of (b)(4)units in 1 lot number was built on 17feb2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of the defect.An investigation was performed and the root cause was determined to be excess solvent added to the connection site.H3 other text : see h10.

• Brand Name: BD ALARIS SMARTSITE 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 ; 8015296192
• MDR Report Key: 14718024
• Report Number: 9616066-2022-00718
• Device Sequence Number: 2135558
• Product Code: FPA
• UDI-Device Identifier: 37613203012288
• UDI-Public: 37613203012288
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 07/26/2022

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: 11/05/2024
• Device Model Number: 20159E
• Device Catalogue Number: 20159E
• Device Lot Number: 21119807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2021
• 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