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

Catalog Number MZ1000

Device Problem Blocked Connection (2888)

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

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one mz1000 sample was received without packaging for investigation.No connecting products were returned to assist the investigation.A visual inspection of the returned sample did not identify any product defects or manufacturing defects which could have contributed to the customer's experience.Functional testing was performed by connecting a retained 50ml bd plastipak syringe and a three way tap from stock to the maxzero component; in each instance a secure connection was observed and no disconnections were identified.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects that could have 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.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the mz1000 product.

Event Description

It was reported that maxzero needleless connector was loose.The following information was provided by the initial reporter: this is a report about a connection issue of mz1000.According to the customer's report, the connection of the connector to the iv line is loose.

• 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: 12170476
• MDR Text Key: 261735967
• Report Number: 9616066-2021-51521
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/14/2021
• 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