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

Catalog Number MZ9270

Device Problem Packaging Problem (3007)

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

Event Date 02/06/2022

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd had open package where sterility was compromised the following information was received by the initial reporter with the following verbatim: maxzero ext set packaging dv failure please let us know what the risk evaluation for this failure is, any sa or other action.For failure sample information, please contact hitesh, product / catalogue number:mz5305, mz5306, mz5309, mz5310, mz9265, mz9266, mz9270, mz9271, mz9279.

Event Description

No additional info.

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaint that there was a packaging failure could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.H3 other text : see h10 below.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S)
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18931484
• MDR Text Key: 338317975
• Report Number: 9616066-2024-00425
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403240737
• UDI-Public: (01)10885403240737
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MZ9270
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1