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

Catalog Number MZ9275

Device Problem Break (1069)

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

Event Date 12/20/2022

Event Type  malfunction  

Event Description

It was reported while using maxzero multi-fuse extension set with needleless connector breakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: infant with dual lumen fem line.Proximal port with quadfuse for med infusion.This rn disconnected quadfuse to flush port with heparin.While putting the green cap on quadfuse, the hub broke off.Charge rn notified.

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 while using maxzero multi-fuse extension set with needleless connector breakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: infant with dual lumen fem line.Proximal port with quadfuse for med infusion.This rn disconnected quadfuse to flush port with heparin.While putting the green cap on quadfuse, the hub broke off.Charge rn notified.

Manufacturer Narrative

Investigation summary no product or photo was returned by the customer.The customer complaint of hub breaking off while putting the cap on could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material mz9275 because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.

• Brand Name: MAXZERO MULTI-FUSE EXTENSION SET WITH 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16433118
• MDR Text Key: 310185215
• Report Number: 9616066-2023-00258
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403240765
• UDI-Public: (01)20885403240765
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140831
• 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,Followup
• Report Date: 02/24/2023

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: MZ9275
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/14/2023
• 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