MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXZERO NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number MZ1000-07

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problems Hypoxia (1918); Chemical Exposure (2570)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: no product or photo was returned by the customer.The customer complaint of leakage 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 mz1000-07 because a lot number was not provided by the customer.Due to no sample received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: due to no sample received, an investigation could not be performed and a root cause could not be determined.

Event Description

It was reported that the maxzero needleless connector experienced cracks, and leakage.The following information was provided by the initial reporter: per vanessa¿s law compliance, health canada website has recently uploaded reports that they have received since november 2020.Unfortunately we do not have any additional information nor customer contact information.These events were pulled from health canada medical device incidents database.Crack, fluid leak.

• Brand Name: MAXZERO 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
• MDR Report Key: 12329088
• MDR Text Key: 266941252
• Report Number: 9616066-2021-51799
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403230194
• UDI-Public: 50885403230194
• Combination Product (y/n): N
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 07/21/2021

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
• Device Operator: Other
• Device Model Number: MZ1000-07
• Device Catalogue Number: MZ1000-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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