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

Catalog Number 20039E

Device Problem Disconnection (1171)

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

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd alaris smartsite extension set separated the following information was received by the initial reporter with the following verbatim: tubing getting disconnected from picc line twice in 24hrs.Product: al20039e.

Manufacturer Narrative

Dhr: no lot provided in initial mdr - provided by customer.No product or photo was returned by the customer.The customer complaint of connection issues could not be verified due to the product not being returned for failure investigation.A device history record review for material# 20039e and lot# 23095677 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12oct2023.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.

Event Description

Material #: 20039e, batch#: 23095677.

• 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: 18539513
• MDR Text Key: 333498942
• Report Number: 9616066-2024-00044
• 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: 03/14/2024

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: 12/28/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1