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

Catalog Number MZ1000

Device Problem Backflow (1064)

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

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: a mz1000 product was not available for investigation, however the customer indicates that blood backflow was observed after the maxzero had been disconnected from the infusion set.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.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.Under certain circumstances it is possible for blood to back flow into the maxzero; such a phenomenon can occur if the patient has high blood pressure or if the patients arm is extended and is hanging below the patients heart.As stated in the directions for use "clamp line when not in use as a safety precaution", "flush the maxzero after each use with normal saline or in accordance with facility protocol." and "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.Investigation conclusion: a mz1000 product was not available for investigation.No further information was available to assist the investigation in this instance.

Event Description

It was reported that the maxzero needleless connector experienced blood backflow during infusion.The following information was provided by the initial reporter: mz1000 was connected to picc.Backflow of blood into the iv route was confirmed.It occurred within 24 hours after locking.

• Brand Name: MAXZERO NEEDLELESS CONNECTOR
• Type of Device: NEEDLESS CONNECTOR
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• MDR Report Key: 12200563
• MDR Text Key: 264936949
• Report Number: 9616066-2021-51573
• 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
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MZ1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2021
• 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