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	MPX5300-C
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd maxplus¿ pressure rated extension set with needleless connector and y-site separated at the boned joint during use.The following information was provided by the initial reporter: "failure of a bonded joint on their extension set.The product which failed during pt care was not kept.However, the assistant nurse manager at the mwh ed stated that other units he ¿tested¿ have also come apart relatively easily at the bonded joint.".
Event or Problem Description
It was reported that the bd maxplus¿ pressure rated extension set with needleless connector and y-site separated at the boned joint during use.The following information was provided by the initial reporter: "failure of a bonded joint on their extension set.The product which failed during pt care was not kept.However, the assistant nurse manager at the mwh ed stated that other units he ¿tested¿ have also come apart relatively easily at the bonded joint.".
Additional Manufacturer Narrative
H6: investigation summary one unused sample was received and tested by our quality team.The set was tested thoroughly and there were no issues with leakage after infusion.The set was also pull tested with greater tensile force than should ever be applied in a clinical setting and no separation was realized.Without further information like photos of the affected device or the device itself for testing the complaint of separation cannot be verified and the root cause remains unknown.A device history record review for model mpx5300-c lot number 22109049 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.H3 other text : see h10.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16850308
• Report Number: 9616066-2023-00799
• Device Sequence Number: 6564829
• Product Code: FPA
• UDI-Device Identifier: 10885403237218
• UDI-Public: 10885403237218
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/05/2023

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 Expiration Date: 10/04/2025
• Device Catalogue Number: MPX5300-C
• Device Lot Number: 22109049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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