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

Model Number MZ5302

Device Problems Leak/Splash (1354); Incomplete or Inadequate Connection (4037)

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

Event Date 06/06/2023

Event Type  malfunction  

Event Description

It was reported that during use with an unspecified amount of bd maxzero¿ multi-fuse extension set with needleless connector there were connection issues that resulted in leakage.This is the 1st of 2 occurrences.Verbatim: customer reported that bd maxzero minibore pressure rated extension sets seem to have a quality issue at the connector that attaches to the iv hub.They report that several do not align well when attached leading to leaking around the site.Leaking at attachment site needing dressing changes.

Manufacturer Narrative

H.6.Investigation summary: a complaint of set not properly connecting, causing leakage was received from the customer.A photo of the packaging was received from the customer.A device history record review for model mz5302 lot number 23049222 was performed.The search showed that a total of 38,403 units in 1 lot number were built on (b)(6) 2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

Event Description

It was reported that during use with an unspecified amount of bd maxzero¿ multi-fuse extension set with needleless connector there were connection issues that resulted in leakage.This is the 1st of 2 occurrences.Verbatim: customer reported that bd maxzero minibore pressure rated extension sets seem to have a quality issue at the connector that attaches to the iv hub.They report that several do not align well when attached leading to leaking around the site.Leaking at attachment site needing dressing changes.

Manufacturer Narrative

Investigation summary: a complaint of set not properly connecting, causing leakage was received from the customer.A photo of the packaging was received from the customer.From the received photo, the defect could not be confirmed.A device history record review for model mz5302 lot number 23049222 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• Brand Name: BD 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17312952
• MDR Text Key: 319411590
• Report Number: 9616066-2023-01415
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230554
• UDI-Public: 10885403230554
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

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: Health Professional
• Device Model Number: MZ5302
• Device Catalogue Number: MZ5302
• Device Lot Number: 23049222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• 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