MAUDE Adverse Event Report: MAXZERO NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number MZ1000-07

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the maxzero needleless connector experienced component separation.The nurse rinsed her eye at an eye wash station, and received medical intervention.The specific medical intervention administered and its outcome have not been specified.The following information was provided by the initial reporter: material #: mz1000-07, batch/lot #: unknown.The nurse was drawing back blood from a central line with a syringe through the blue cap and.She immediately rinsed her right eye at the eye wash station for 5 minutes.What type of device was used to collect the blood: slip-tip syringe, luer-lock syringe, or vacutainer?: it was from a 3 way stopcock and the nurse was actually putting on a pressure cap onto the stopcock that was connected to patient.To be safe, she primed the pressure cap first and connected to the stopcock then she withdraw a little of blood from the stopcock to ensure no air was in the connection.She used a 5 cc syringe to withdraw the blood and when she disconnected the syringe from the cap, she felt a drop of blood splashed into her eye.Death: no.Exposure to blood/bodily fluid: yes.Medical intervention other than first aid: yes.Other actions taken: yes.

Manufacturer Narrative

H.6.Investigation: one used sample was received and investigated by our quality team.The sample was caked with blood even on the outside so it was necessary to soak the connector in warm water before testing could be performed.The sample was infused with fluid multiple times and no leak was noticed.Using a syringe and different types of male luers, an attempt was made to force a seal stick leak but this was not successful either.Due to this being an issue with this connector in the past, the customer's complaint of leakage has been verified.A device history record review could not be performed because a lot number was not provided by the customer.

Event Description

It was reported that the maxzero needleless connector experienced component separation.The nurse rinsed her eye at an eye wash station, and received medical intervention.The specific medical intervention administered and its outcome have not been specified.The following information was provided by the initial reporter: material #: mz1000-07 and batch/lot #: unknown.The nurse was drawing back blood from a central line with a syringe through the blue cap and.She immediately rinsed her right eye at the eye wash station for 5 minutes.What type of device was used to collect the blood: slip-tip syringe, luer-lock syringe, or vacutainer?: it was from a 3 way stopcock and the nurse was actually putting on a pressure cap onto the stopcock that was connected to patient.To be safe, she primed the pressure cap first and connected to the stopcock then she withdraw a little of blood from the stopcock to ensure no air was in the connection.She used a 5 cc syringe to withdraw the blood and when she disconnected the syringe from the cap, she felt a drop of blood splashed into her eye.Death: no.Exposure to blood/bodily fluid: yes.Medical intervention other than first aid: yes.Other actions taken: yes.

• Brand Name: MAXZERO NEEDLELESS CONNECTOR
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12011500
• MDR Text Key: 261943481
• Report Number: 9616066-2021-51324
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ1000-07
• Device Catalogue Number: MZ1000-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Date Manufacturer Received: 08/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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