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

Catalog Number MZ1000

Device Problem Complete Blockage (1094)

Patient Problem Fever (1858)

Event Date 04/24/2021

Event Type  Injury  

Manufacturer Narrative

Investigation summary: an mz1000 product was not available for investigation; however the customer confirmed that the complaint sample was from lot 20085530.No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.A review of the production records for lot 20085530 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Please note as stated in the directions for use of the maxzero valve "flush the maxzero after each use with normal saline or in accordance with facility protocol." "failure to properly prime the device can result in reflux." a review of the customer feedback database indicates that reports of this nature against the maxzero product occur at a low frequency and have not been attributable to a product defect or manufacturing issue.

Event Description

It was reported that the maxzero needleless connector had flow issues that required to patient to receive three separate curatives in less than 72 hours.The following information was provided by the initial reporter, translated from spanish to english: patient with diagnosis of ileus transt.With epicutaneous catheter in msi ulnar fold.Catheter with positive pressure adapter (safeflow needle-free connector), catheter that repeatedly presented return despite having this device, also permeabilization of the catheter and 3 cures in less than 72 hours, finally they decided to withdraw the adapter and the catheter continues to function and does not return.

• 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
• 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: 11957540
• MDR Text Key: 254872609
• Report Number: 9616066-2021-51272
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/05/2023
• Device Catalogue Number: MZ1000
• Device Lot Number: 20085530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 10 DA