MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO¿ EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MZX5306

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d.4.Medical device lot #: 22119054, d.4.Medical device expiration date: 05-nov-2025, h.4.Device manufacture date: (b)(4), d.4.Medical device lot #: 22119055, d.4.Medical device expiration date: 07-nov-2025, h.4.Device manufacture date: (b)(4).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd maxzero¿ extension set was defective with lot# 22119054 105 were affected and 22119055 440 were affected.The following information was provided by the initial reporter: marin general had more defective product they received that needs to be returned and credited.

Event Description

It was reported that the bd maxzero¿ extension set was defective with lot# 22119054 105 were affected and 22119055 440 were affected.The following information was provided by the initial reporter: marin general had more defective product they received that needs to be returned and credited.

Manufacturer Narrative

Investigation summary: one photo was received for quality investigation.The customer complaint of tubing defective/damaged could not be confirmed with the photo submitted.The difference of the male luer connectors is due to a design change in the extension set assembly.The photo submitted by the customer shows the difference in the male luers they received; however, it does not show the leaking or connection issues that the customer is reporting.A device history record review for model mzx5306 lot numbers 22119054 & 22119055 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause for the issues reported could not be determined due to a physical sample not being available for testing.

• Brand Name: BD MAXZERO¿ 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17500204
• MDR Text Key: 320809120
• Report Number: 9616066-2023-01714
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403463799
• UDI-Public: (01)20885403463799
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171957
• 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: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MZX5306
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• 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