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

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2023

Event Type  malfunction  

Event Description

It was reported that 2 bd maxguard¿ pressure rated extension set with y-site(s) experienced flow issue.This complaint was created to capture the 2nd 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 two 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".

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 # 4600210000-2023-8009.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: 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.

Event Description

It was reported that 2 bd maxguard¿ pressure rated extension set with y-site(s) experienced flow issue.This complaint was created to capture the 2nd 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".

• Brand Name: BD MAXGUARD¿ PRESSURE RATED EXTENSION SET WITH Y-SITE(S)
• Type of Device: 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: 16781622
• MDR Text Key: 313999687
• Report Number: 9616066-2023-00740
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403237553
• UDI-Public: (01)10885403237553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX5301
• Device Lot Number: 22099253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 34 MO
• Patient Sex: Female
• Patient Weight: 70 KG