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

Catalog Number	20043E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris smartsite extension set separated the following information was received by the initial reporter with the : product description: smartsite extension set origin of the issue: product failure//design detail: extension tubing pulled apart at the connection point to the smartsite valve.
Additional Manufacturer Narrative
It was reported by the customer that extension tubing pulled apart at the connection point to the smartsite valve.No product or photo was returned by the customer.The customer complaint of separation other component - no leak could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model 20043e lot number 23125339 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 14dec2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.Materials: 20043e batch#: 23125339 it was reported by the customer that extension tubing pulled apart at the connection point to the smartsite valve.Rcc received a complaint via email.Email(s) attached.Facility contact: (b)(6) department: materials management phone number: (b)(60 email: (b)(6) product catalog number: 20043e product description: smartsite extension set origin of the issue: product failure//design detail: extension tubing pulled apart at the connection point to the smartsite valve.Number of occurrences: 1.0 sample available: true lot number: 23125339 reported to vendor representative: yes.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18887438
• Report Number: 9616066-2024-00404
• Device Sequence Number: 7774092
• Product Code: FPA
• UDI-Device Identifier: 20885403234870
• UDI-Public: (01)20885403234870
• 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
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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: 20043E
• Device Lot Number: 23125339
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown