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

Catalog Number MS3500-15

Device Problem Defective Component (2292)

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

Event Date 01/21/2024

Event Type  malfunction  

Event Description

It was reported that bd alaris secondary set was damaged the following information was received by the initial reporter with the following verbatim: elderly male with history of meckel¿s diverticulitis and recent abdominal pain.Procedure: infusion of zosyn.The plastic tip of the secondary tubing was found to be broken off and inside the bag of zosyn.No known harm to patient.Lot number : 23119196.Model number :- ms3500-15.

Manufacturer Narrative

A2.Patient¿s birthday was not provided, 01-jan-xxxx was used based on age of patient e4.The initial reporter also notified the fda on 02 feb, 2024.Medwatch report # mw3600840000-2024-8020.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

No additional information was provided.

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaint of plastic tip broken off inside of bag could not be verified due to the product not being returned for failure investigation.Device history record review for model ms3500-15 lot number 23119196 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 21nov2023.The root cause of this failure could not be identified without a failure investigation.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: BD ALARIS SECONDARY 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: 18775619
• MDR Text Key: 337439225
• Report Number: 9616066-2024-00300
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

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: MS3500-15
• Device Lot Number: 23119196
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 77 KG