MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MZ5302

Device Problems Leak/Splash (1354); Difficult to Remove (1528); Difficult or Delayed Separation (4044)

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

Event Date 10/13/2021

Event Type  malfunction  

Event Description

It was reported that the bd maxzero¿ multi-fuse pressure rated extension set with needleless connector end cap was difficult to disconnect and blood leaked from it during use.The following information was provided by the initial reporter: "several nurses in hhvi have been having issues with this iv pigtail.The end cap is very difficult to unscrew (so much so that you occasionally need hemostats to remove it).Then in turn once you do remove it, it does not always thread properly to the end of an angiocath and some blood leaks around it.We felt that this poses a safety issue.If in an emergency it should not be this difficult and time consuming to get the cap off.I think that this item replaced a baxter interlink extension set (2n3374) that we used to use.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: one sample was received for quality investigation.The customer complaint of connection issue - leakage could not be verified by investigation.Evaluation of the returned sample began with removing the plastic end cap from the male luer connection.The customer stated that this end cap was difficult to remove.Upon evaluation the end cap was removed without any issues and not excessive force was needed to remove the end cap.The extension set was connected to an infusion set and a simulated infusion was conducted using normal saline.There was no leakage noticed at the max zero connector.The male luer connection end was then connected to a sample extension set female adapter and pressure was applied using a syringe filled with water.No leakage was seen from the extension set.No additional issues were discovered on the extension set.A device history record review for model mz5302 lot number 21055444 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 06may2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause for the issue reported could not be determined due to the fact that the failure could not be replicated.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¿ MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12787753
• MDR Text Key: 280594729
• Report Number: 9616066-2021-52399
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140831
• 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
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MZ5302
• Device Lot Number: 21055444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2021
• 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