MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MPX5302-C
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd maxplus pressure rated extension set with needleless connector and y-site extension tubing fell apart at the y-site connection.The following information was provided by the initial reporter: the patient's iv extension tubing fell apart at the y-site connection.
Additional Manufacturer Narrative
Correction: b5: describe event or problem: it was reported that bd maxplus pressure rated extension set with needleless connector and y-site extension tubing fell apart at the y-site connection and leaked.The following information was provided by the initial reporter: the patient's iv extension tubing fell apart at the y-site connection.H5: imdrf annex a grid: a0413, a0504.
Event or Problem Description
It was reported that bd maxplus pressure rated extension set with needleless connector and y-site extension tubing fell apart at the y-site connection and leaked.The following information was provided by the initial reporter: the patient's iv extension tubing fell apart at the y-site connection.
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.It was reported by the customer that the patient's iv extension tubing fell apart at the y-site connection could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
It was reported that bd maxplus pressure rated extension set with needleless connector and y-site extension tubing fell apart at the y-site connection and leaked.The following information was provided by the initial reporter: the patient's iv extension tubing fell apart at the y-site connection.

• Brand Name: BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE
• 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: 17481189
• Report Number: 9616066-2023-01679
• Device Sequence Number: 13005784
• Product Code: FPA
• UDI-Device Identifier: 10885403237232
• UDI-Public: (01)10885403237232
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2023

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: MPX5302-C
• Device Lot Number: UNKNOWN
• 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: 07/28/2023
• Supplement Date Received by Manufacturer: 08/21/2023; 10/15/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 08/21/2023; 10/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown