MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE, STOPCOCK AND MANIFOLD; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MX4436

Device Problem Packaging Problem (3007)

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

Event Date 08/15/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd maxguard¿ extension set with needleless y-site, stopcock and manifold the sterility was compromised.There was no report of patient impact.The following information was provided by the initial reporter: seals on 2 different max guards were improperly folded leading to questions about sterility.

Manufacturer Narrative

Investigation summary: a complaint of packaging not being folded properly was received from the customer.No product or photo was returned by the customer.The customer complaint of packaging seal integrity poor/ questionable could not be verified due to the product not being returned for failure investigation.A device history record review for model mx4436, lot number 23049272 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.

Event Description

It was reported while using bd maxguard¿ extension set with needleless y-site, stopcock and manifold the sterility was compromised.There was no report of patient impact.The following information was provided by the initial reporter: seals on 2 different max guards were improperly folded leading to questions about sterility.

• Brand Name: BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE, STOPCOCK AND MANIFOLD
• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17671280
• MDR Text Key: 322522675
• Report Number: 9616066-2023-01832
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403237478
• UDI-Public: (01)10885403237478
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• 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: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MX4436
• Device Lot Number: 23049272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• 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