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

Catalog Number	MX5302
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4 device expiration date: unknown.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd maxguard pressure rated extension set with y-site(s) experienced leakage.The following information was provided by the initial reporter: extension set at connection to iv catheter (20g) while infusing normal saline via lifeflow, nurse double checked that extension set was screwed in all the way and correctly into iv catheter.Extension set was removed and replaced, no further leaking or issues with new extension set.
Event or Problem Description
It was reported that the bd maxguard pressure rated extension set with y-site(s) experienced leakage.The following information was provided by the initial reporter: extension set at connection to iv catheter (20g) while infusing normal saline via lifeflow, nurse double checked that extension set was screwed in all the way and correctly into iv catheter.Extension set was removed and replaced, no further leaking or issues with new extension set.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.It was reported by the customer that extension set was screwed in all the way and correctly into iv catheter could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model # 30203e 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.

• Brand Name: BD MAXGUARD PRESSURE RATED EXTENSION SET WITH 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16948416
• Report Number: 9616066-2023-00926
• Device Sequence Number: 12400780
• Product Code: FPA
• UDI-Device Identifier: 10885403237560
• UDI-Public: 10885403237560
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/19/2023

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: MX5302
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 07/05/2023
• 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