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

Catalog Number MX4439

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 08/07/2023

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 that bd maxguard extension set with needleless y-site(s) and stopcock that an endcap is missing from the stopcock.The following information was provided by the initial reporter: ¿we have some tubing that is missing a cap.The item# is wd#2843292 ref# mx4439 lot# 23059238 made by bd.So far this is the only lot that we have found that is missing one of the caps on the stopcock portion of the tubing.¿.

Manufacturer Narrative

One photo was received for quality investigation.The customer complaint of misassembly was verified by evaluation of the photo.The photo received shows that the stopcock of the extension set assembly is missing a safety cap.The issue was identified with the product still in the packaging and unused.A device history record review for model mx4439 lot number 23059238 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 15may2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the issue seen in this complaint is the failure of the assembly staff to place a safety cap on the open ports of the stopcock component due to being distracted during the assembly process.A quality alert has been generated to reinforce the correct assembly sequence.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 narrative below.

Event Description

Material#: mx4439; lot#: 23059238.It was reported by customer that some tubing that is missing a cap.Verbatim: ¿we have some tubing that is missing a cap.The item# is wd#2843292 ref# mx4439 lot# 23059238 made by bd.So far this is the only lot that we have found that is missing one of the caps on the stopcock portion of the tubing.¿.

• Brand Name: BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S) AND STOPCOCK
• 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: 17569407
• MDR Text Key: 321675451
• Report Number: 9616066-2023-01769
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403237485
• UDI-Public: (01)10885403237485
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

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: Other
• Device Catalogue Number: MX4439
• Device Lot Number: 23059238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 11/15/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• 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