MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXGUARD PRESSURE RATED T-CONNECTOR EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MPXT5302-C
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd maxguard pressure rated t-connector extension set with needleless connector separated the following information was received by the initial reporter with the following verbatim.It was reported by customer that spin collar on t-connector comes off easil.
Additional Manufacturer Narrative
It was reported by customer that spin collar on t-connector comes off easily.Two hundred samples were received for quality evaluation.Fifty-nine samples were tested for the reported failure.Fourty-nine of the fifty-nine samples failed as reported.The customer complaint of separation was confirmed.The manufacturing site found the root cause for the t-connector coming apart easily is the lip on the male luer.This 'lip' that retains the luer collar was found to be out of specification.This lip was too small, allowing the collar to loosely slide off the luer.This issue has been escalated into a funded project at the manufacturing site to address and mitigate the risk of this issue recurring.This project includes a work order to replace the slide core pin for the mold m438, a quality notification to contain lots in process, and a quality alert to communicate to personnel the issue.
Event or Problem Description
Material# mpxt5302-c, batch# 24079253.It was reported by customer that spin collar on t-connector comes off easily verbatim: spin collar on t-connector comes off easily.

• Brand Name: BD MAXGUARD PRESSURE RATED T-CONNECTOR EXTENSION SET WITH NEEDLELESS CONNECTOR
• Common Device Name: 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: 20241741
• Report Number: 9616066-2024-01340
• Device Sequence Number: 20866695
• Product Code: FPA
• UDI-Device Identifier: 10885403274657
• UDI-Public: (01)10885403274657
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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
• Operator of Device: Other
• Device Catalogue Number: MPXT5302-C
• Device Lot Number: 24079253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown