MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO MINIBORE PRESSURE RATED EXTENSION SET, REMOVABLE IV CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZXT5307
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.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 maxzero minibore pressure rated extension set, removable iv connector there was component separation.There was no report of patient impact.The following information was provided by the initial reporter: infusion rn state that the product is defective.He states that the spin collar is able to be removed whereas the old smartsite product (20043e) you could not remove.¿t-port fell apart when hooking to iv catheter.Hub came apart from luer lock.¿ on the si event.
Event or Problem Description
It was reported while using bd maxzero minibore pressure rated extension set, removable iv connector there was component separation.There was no report of patient impact.The following information was provided by the initial reporter: infusion rn state that the product is defective.He states that the spin collar is able to be removed whereas the old smartsite product (20043e) you could not remove.¿t-port fell apart when hooking to iv catheter.Hub came apart from luer lock.¿ on the si event.
Additional Manufacturer Narrative
H.6.Investigation summary: no photo or sample was received for the customer's complaint of separation.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.A device history record review could not be performed because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD MAXZERO MINIBORE PRESSURE RATED EXTENSION SET, REMOVABLE IV CONNECTOR
• 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: 17483781
• Report Number: 9616066-2023-01687
• Device Sequence Number: 8942541
• Product Code: FPA
• UDI-Device Identifier: 50885403471153
• UDI-Public: (01)50885403471153
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 08/24/2023

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: MZXT5307
• 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: 07/20/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/09/2023
• 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