MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXGUARD EXTENSION SE T WITH NEEDLELESS Y-SITE(S) AND STOPCOCK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX4450
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxguard extension se t with needleless y-site(s) and stopcock was occluded.The following information was received by the initial reporter with the verbatim: we have been having issues with the mx4450 extension sets with 4-way stopcocks.I know we had the same problem maybe a year ago and some bad lot #'s were identified.Have you had any reports of this happening with the lot # below? this is a safety incident reported by our surgery team.Please see highlighted sections below for the info you may need to report this.Thank you.Material mx4450 lot 22099402- samples are available.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Pr (b)(4) - follow up mdr for device evaluation.No product or photo was returned by the customer.The customer complaint of occlusion in the sets could not be verified due to the product not being returned for failure investigation.Device history record review for model mx4450 lot number 22099402 was performed.The search showed that a total of (b)(4)units in 1 lot number was built on 22sep2022.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.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.

• Brand Name: BD MAXGUARD EXTENSION SE T WITH NEEDLELESS Y-SITE(S) AND STOPCOCK
• 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: 18278773
• Report Number: 9616066-2023-02342
• Device Sequence Number: 6846416
• Product Code: FPA
• UDI-Device Identifier: 50885403274679
• UDI-Public: (01)50885403274679
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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
• Operator of Device: Other
• Device Catalogue Number: MX4450
• Device Lot Number: 22099402
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown