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

Catalog Number	ME2010
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxguard extension set was difficult to disconnect.The following information was received by the initial reporter with the following: it was reported by customer that when disconnect syringe med tubing for a vec gtt (to change the line) and the plastic broke, and a piece remained in the stopcock.They have been having trouble disconnecting lines.When attempting to disconnect the male leur of item#: me2010 that was connected to the stopcock in the photo, the male leur broke off and remained in the stopcock.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: it was reported by customer that when attempting to disconnect the male leur that was connected to a stopcock the male leur broke off and remained in the stopcock.One sample was received for quality evaluation.Visual inspection of the sample submitted shows that the male distal luer is cracked inside a stopcock port.The portion of the male luer that was cracked in the stopcock was cut out to determine if the luer was fused in anyway to the stopcock fitting.The cracked off portion of the male luer adapter was not fused to the stopcock fitting and was removed easily once it was able to be grabbed with pliers.Further examination of the luer body indicates that the connection was bent in attempt to disconnect the connection, causing it to break.The customer complaint of connection issue - difficult to disconnect could not be confirmed.A root cause for the report failure was not determined because once the piece of broken luer was able to reach, it was easily removed and there was no evidence that it was fused to the female luer connection of the stopcock.A device history record review could not be performed because the lot number is unknown.
Event or Problem Description
Sample.

• 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: 21511302
• Report Number: 9616066-2025-00403
• Device Sequence Number: 7962371
• Product Code: FPA
• UDI-Device Identifier: 10885403236235
• UDI-Public: (01)10885403236235
• 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): 04/23/2025

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: ME2010
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 04/24/2025
• 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