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	MX5301
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.2.Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.E.4.Fda notified?: the initial reporter also notified the fda via medwatch # (b)(4).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 blood leaked out of the bd maxguard¿ pressure rated extension set with y-site(s) connection port to the iv tubing when starting the iv for the c-section.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "describe the event or problem: registered nurse starting iv on patient who is here this morning for scheduled cesarean section.Iv placed on right arm without difficulty, used bd max guard pressure rated extension set with needleless y site.Once connected to iv line, blood dripping out of the connection port where extension set connects to regular iv tubing.Nurse double checked connection making sure it was tightened completely and continued to leak.Care was paused to replace the maxguard extension set, and currently appears to be functioning without leaks.We have had 2 other issues with this same lot number of these bd maxguard extension sets.The manufacturers have reached out to me and asked for the specific malfunctioning sites, but the nurse didn't collect it.The other events were regarding these extension sets not flowing properly, but they didn't leak.What was the original intended procedure? : cesarean section".
Event or Problem Description
It was reported that blood leaked out of the bd maxguard¿ pressure rated extension set with y-site(s) connection port to the iv tubing when starting the iv for the c-section.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "describe the event or problem: registered nurse starting iv on patient who is here this morning for scheduled cesarean section.Iv placed on right arm without difficulty, used bd max guard pressure rated extension set with needleless y site.Once connected to iv line, blood dripping out of the connection port where extension set connects to regular iv tubing.Nurse double checked connection making sure it was tightened completely and continued to leak.Care was paused to replace the maxguard extension set, and currently appears to be functioning without leaks.We have had 2 other issues with this same lot number of these bd maxguard extension sets.The manufacturers have reached out to me and asked for the specific malfunctioning sites, but the nurse didn't collect it.The other events were regarding these extension sets not flowing properly, but they didn't leak.What was the original intended procedure? : cesarean section.".
Additional Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.The customer complaint of leakage at connection port could not be verified due to the product not being returned for failure investigation.Device history record review for model mx5301 lot number 22099253 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16748695
• Report Number: 9616066-2023-00704
• Device Sequence Number: 8626853
• Product Code: FPA
• UDI-Device Identifier: 10885403237553
• UDI-Public: 10885403237553
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 04/27/2023

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: Health Professional
• Device Expiration Date: 09/13/2025
• Device Catalogue Number: MX5301
• Device Lot Number: 22099253
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/16/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2022
• 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 Age: 34 YR
• Patient Sex: Female
• Patient Weight: 70 KG