MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD EXT SET DEHP FREE 1.2MF; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	10012866
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The initial reporter also notified the fda: medwatch # (b)(4) in dec 2023.Patient identified to be 5 months old at the time of medwatch report.
Event or Problem Description
It was reported that bd ext set dehp free 1.2mf tubing disconnected or broke and leaked.The following information was provided by the initial reporter: registered nurse (rn) turned on the lights to assess the patient and noticed backflow of blood into tubing set.Rn investigated and found that the lipid tubing filter had disconnected/broken, leaving lipids to spill onto floor and blood to backflow into the trifuse.Rn immediately stopped the lipids, clamped the old tubing and primed new tubing.Broken tubing was saved.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of leakage from disconnected filter could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.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 or Problem Description
No additional information was provided.

• Brand Name: BD EXT SET DEHP FREE 1.2MF
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 18813251
• Report Number: 9616066-2024-00337
• Device Sequence Number: 12839027
• Product Code: FPA
• UDI-Device Identifier: 50885403233775
• UDI-Public: (01)50885403233775
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 06/06/2024

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: Health Professional
• Device Expiration Date: 09/26/2026
• Device Catalogue Number: 10012866
• Device Lot Number: 23099412
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 5 MO
• Patient Sex: Male
• Patient Weight: 9 KG