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

Catalog Number	20028E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite extension set was leaking at the connection of the tubing and the collar.The following information was provided by the initial reporter: it was reported by the customer that they continue to have issues w/ these me2020 60 inch bd maxguard microbore tubing.Verbatim: ¿ can you please provide more details regarding the failure/issue reported? also, some were leaking around where the tubing goes into the collar.¿ are you able to advise the occurrence date(s)? january 2023 to present ¿ if there was patient involvement, was there any adverse event or serious injury reported? no harm ¿ was there a delay of, or change in, the course of treatment due to the event? no, other than the nurse having to go get additional tubing.Additionally, the collar not being stationary resulted in the collar migrating down the tubing making it hard to attach and was concerning as this causes risk of contamination.
Additional Manufacturer Narrative
B3.The date received by manufacturer 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.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
No product or photo was returned by the customer.It was reported by the customer that there was leaking around where the tubing goes into the collar, and the collar was not stationary.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 20028e lot number 22049001 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02apr2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17647403
• Report Number: 9616066-2023-01820
• Device Sequence Number: 20708514
• Product Code: FPA
• UDI-Device Identifier: 07613203012393
• UDI-Public: (01)07613203012393
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2023

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: 04/01/2025
• Device Catalogue Number: 20028E
• Device Lot Number: 22049001
• 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: 08/14/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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