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

Model Number	MX9433
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Dizziness (2194); Discomfort (2330)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.2.Patient¿s birthday was not provided, 01jan1988 was used based on age of patient.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd maxguard administration set with needleless y-site(s) there was component separation and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: issue: started an iv.Went to attach the tubing to start the lr and the lure lock would not attach and lr leaked everywhere.Had to get new tubing and prime a whole new line.While this was going on the patient was nauseous and about to pass out from everything that was happening.Patient was very uncomfortable and disconcerting to the patient.This has happened now two times with the same problem.Needs to be fixed.Background: event date: (b)(6) 2023 ih #: 32011614 mfg #: mx9433 description: set admin iv 130in 15drop sample available : y/n (if sample is available and would like it sent for your evaluation, please reply all and attach a return shipping label via email) lot #: 23029244 assessment: was there injury? no - are you able to provide the patient identifiers (name, age, date of birth, etc.) if available.Male, 35 yo - was there any adverse event or serious injury to patient or healthcare professional? if yes, please provide the details.No.
Additional Manufacturer Narrative
Investigation summary: 3 samples were received and tested by our quality team.One set was separated upon receipt and the customer's complaint was verified.Visual analyses under microscope was used and the set had a clear lack of solvent at the end that was supposed to be inserted into the needle free connector y-site.The manufacturer was notified of this issue and they have found the root cause of this separation to be a lack of solvent applied during the assembly process.A quality alert was initiated to further enforce correct solvent application and ensure this failure no longer occurs.A device history record review was performed and there were no relevant production issues or quality notifications with the mat # mx9433 sets of the following lots: 23029244 ((b)(4) units produced on (b)(6) 2023), 22129074 ((b)(4) units produced on (b)(6) 2022).
Event or Problem Description
No additional information.

• Brand Name: BD MAXGUARD ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S)
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17330444
• Report Number: 9616066-2023-01459
• Device Sequence Number: 6118304
• Product Code: FPA
• UDI-Device Identifier: 50885403237780
• UDI-Public: (01)50885403237780
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024

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 Model Number: MX9433
• Device Catalogue Number: MX9433
• Device Lot Number: 23029244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Male