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

Catalog Number MZ5303

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 04/20/2023

Event Type  malfunction  

Event Description

It was reported that the bd maxzero¿ multi-fuse pressure rated extension set with needleless connector was loosely connected to the iv hub, causing leakage during use.The following information was provided by the initial reporter: extension set not secured properly to iv hub: male luer at distal end of extension set appears connected and continues to leak at the, the system remains open breaking the integrity of the line.

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary no photo or sample was received for the customer's complaint of leakage.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.A device history record review for model mz5303 lot number 23029020 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.

Event Description

It was reported that the bd maxzero¿ multi-fuse pressure rated extension set with needleless connector was loosely connected to the iv hub, causing leakage during use.The following information was provided by the initial reporter: "extension set not secured properly to iv hub: male luer at distal end of extension set appears connected and continues to leak at the, the system remains open breaking the integrity of the line".

• Brand Name: BD MAXZERO¿ MULTI-FUSE PRESSURE RATED 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: 16928447
• MDR Text Key: 315182779
• Report Number: 9616066-2023-00892
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230561
• UDI-Public: 10885403230561
• 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: 05/15/2023

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: MZ5303
• Device Lot Number: 23029020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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