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

Catalog Number	MX4436
Medical Device Problem Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxguard extension set with needleless y-site(s), stopcock(s) and manifold was damaged the following information was received by the initial reporter with the following verbatim: we have had multiple patients come through surgery and their iv tubing becomes disconnected at the stopcock.Today, we received a patient in pacu after surgery and the clave closest to the patient was backwards.It was forcing the medications to be flushed towards the bag instead of the patient.Catalog#: mx4436.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
The customer reported the smart site was inverted and returned one photo of material mx4436.The photo verified the issue of inverted smart site, proximal and distal sides attached to the wrong tubing.The manufacturing site found the possible root cause of the inverted smart site to be assembler error in not using fixture 2120 correctly.The fixture is designed to help with the smart site orientation when assembling with the tubing.A quality alert was generated 05jun2024 to communicate, reinforce, and correct the sequence of operations for assembler.A device history record review could not be performed on material mx4436 because the lot number is unknown.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 MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S), STOPCOCK(S) AND MANIFOLD
• 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: 19181091
• Report Number: 9616066-2024-00625
• Device Sequence Number: 12613278
• Product Code: FPA
• UDI-Device Identifier: 10885403237478
• UDI-Public: (01)10885403237478
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/17/2024

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: MX4436
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown