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

Catalog Number	MS3500-15
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem Description
No additional information was provided.
Additional 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
• 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: 18775619
• Report Number: 9616066-2024-00300
• Device Sequence Number: 15023001
• Product Code: FPA
• UDI-Device Identifier: 50885403222618
• UDI-Public: (01)50885403222618
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Catalogue Number: MS3500-15
• Device Lot Number: 23119196
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 77 KG