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

Catalog Number 20039E

Device Problems Disconnection (1171); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It was reported that bd alaris smartsite extension set disconnected the following information was received by the initial reporter with the verbatim: tubing getting disconnected from picc line twice in 24hrs.

Manufacturer Narrative

E1: initial reporter facility name - (b)(6).H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

Additional information: investigation results: no product or photo was returned by the customer.The customer complaint of tubing set disconnecting from picc line could not be verified due to the product not being returned for failure investigation.Device history record review for model 20039e lot number 23095677 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13oct2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.

Event Description

Additional information: i have lot# (10)23095677 reported by nursing with the event date being 12/07/23.The reported product event occurred while in use with a patient but no harm was caused.

• Brand Name: BD ALARIS SMARTSITE EXTENSION SET
• Type of Device: 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: 18553019
• MDR Text Key: 333511746
• Report Number: 9616066-2024-00050
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 27613203013820
• UDI-Public: (01)27613203013820
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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
• Device Operator: Other
• Device Catalogue Number: 20039E
• Device Lot Number: 23095677
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1