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

Model Number MZ1000-07

Device Problem Leak/Splash (1354)

Patient Problem Injury (2348)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

Age at time of event: only the patient's age was provided therefore a default date of birth has been listed.Device expiration date: unknown, device manufacture date: unknown.(b)(4).Investigation summary: a complaint of cracked tubing was received from the customer.No product or photo was returned by the customer.The customer complaint of tubing damage 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.The root cause of this failure was not identified as no product was returned.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: the root cause of this failure was not identified as no product was returned.No product will be returned per customer.No investigation was performed.

Event Description

It was reported that the maxzero needleless connector experienced device damage/deformation.The product defect resulted in a serious injury in the form of medical intervention with a second intubation procedure being performed.The following information was provided by the initial reporter: material no.: mz1000-07 lot no.: unknown describe the event or problem: a one-time dose of fentanyl was initiated at 0505 to be given prior to intubation.The dose was initiated, and the intubation process was started.Upon hanging a saline flush, the nurse discovered that there was a crack in the clave/med tubing and the fentanyl had puddled on the ground below the syringe pump.A re-dose of fentanyl was required, and the intubation was traumatic as a result of the failed infusion of the first dose.The neonatal nurse practitioner was at the bedside and was notified immediately of the event.The charge nurse was also made aware and was at the bedside.What was the original intended procedure? : intubation what problem did the user have (check all that apply).¿device failed (e.G.Broke, couldn't get it to work or stopped working) ;.

• 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 22244 ; MX 22244
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10703508
• MDR Text Key: 212299318
• Report Number: 9616066-2020-20126
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403230194
• UDI-Public: 50885403230194
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 2 MO