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

Catalog Number MZ1000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 04/15/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that there was an infection while using maxzero needleless connector.The following information was provided by the initial reporter: customer gets in touch to request guidance on using the luer system device.Closed (bd max zero connector without needle) for the hospital's assistance teams.The patient safety center detected the occurrence of more serious events related to phlebitis in their service and in identifying causes, it observed considerable difficulty of the teams (they have many new professionals due to the pandemic context) in the use of the material in question.

Event Description

It was reported that there was an infection while using maxzero needleless connector.The following information was provided by the initial reporter: customer gets in touch to request guidance on using the luer system device.Closed (bd max zero connector without needle) for the hospital's assistance teams.The patient safety center detected the occurrence of more serious events related to phlebitis in their service and in identifying causes, it observed considerable difficulty of the teams (they have many new professionals due to the pandemic context) in the use of the material in question.

Manufacturer Narrative

H.6.Investigation: an mz1000 sample was not available for investigation of this feedback; however the customer indicates that the health care practitioners experienced issues with using the maxzero device which resulted in an increase in occurrence of phlebitis.A review of the production records for lot 20085529 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined in this instance.Without a sample or additional information regarding the details of the nature of the feedback it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported issue.

• 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: 11825407
• MDR Text Key: 251238325
• Report Number: 9616066-2021-50995
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 08/04/2023
• Device Catalogue Number: MZ1000
• Device Lot Number: 20085529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other