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

Catalog Number MZ5303

Device Problem Packaging Problem (3007)

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

Event Date 12/21/2023

Event Type  malfunction  

Event Description

It was reported that bd maxzero multi-fuse pressure rated extension set had sterility compromised the following information was received by the initial reporter with the following verbatim: describe customer concern, details of event including how the issue was resolved: this is packaging design verification failure.Packaging oq failure.If product made by the oq parameter setting, it may have sterility breach for product.

Manufacturer Narrative

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

Manufacturer Narrative

Mdr made in error- with design verification the material number mz5303 did not fail and no complaint needed to be generated.

Event Description

Material#: mz5303 batch number#: unknown it was reported by customer that packaging design verification failure.Packaging oq failure.If product made by the oq parameter setting, it may have sterility breach for product.Verbatim#: rcc received a complaint via email.Email(s) attached.Describe customer concern, details of event including how the issue was resolved: this is packaging design verification failure.Packaging oq failure.If product made by the oq parameter setting, it may have sterility breach for product.Date of event 12/21/2021 product / catalogue number mz5301, mz5302, mz5303, mz5304, mz5307 product description: maxzero ext set.

• Brand Name: BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET
• 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: 18620117
• MDR Text Key: 335083005
• Report Number: 9616066-2024-00157
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230561
• UDI-Public: (01)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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MZ5303
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• 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