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

Catalog Number	MXT1003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the spin collar fell off and returned photo evidence of material mxt1003.The photo verifies the complaint of spin collar falling off.No physical sample was available for investigation.A device history record review could not be performed because the lot number is unknown.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.This incident has been added to our database of reported incidents.
Event or Problem Description
It was reported that bd maxguard extension set was separated the following information was received by the initial reporter with the following verbatim it was reported by customer that spin collar on item # mxt1003 broken.The spin collar fell off completely.
Additional Manufacturer Narrative
The customer reported the spin collar fell off, and returned photo evidence of material mxt1003.The photo verifies the complaint of spin collar falling off.A physical sample was also sent in at a later date.The physical sample verified the complaint of component damage.A device history record review could not be performed because the lot number is unknown.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.

• Brand Name: BD MAXGUARD EXTENSION SET
• 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: 22023499
• Report Number: 9616066-2025-01230
• Device Sequence Number: 9099587
• Product Code: FPA
• UDI-Device Identifier: 10885403237829
• UDI-Public: (01)10885403237829
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: MXT1003
• Device Lot Number: UNKNOWN
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown