MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. 60 IN NON-DEHP MINIBORE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	ME2010
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It is reported connection issues.Description: having difficulty removing the clear plastic piece on the male end.Also states she has to "seat" the connection multiple times to feel like it is connected correctly.Lastly, there have been numerous occasions where the medication bolus she is administering causes the connection to "pop off" or leak.No other personnel have voiced complaints like this that she is aware of, nor have i heard anything similar in complaints about this from anyone else no patient harm.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
The customer reported connection issues with the male luer on material me2010, lot 25095111.Upon initial visual examination, the set had no defects or abnormalities.The set was manipulated and tested for connection problems at the male luer, but none were found.The complaint could not be verified.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.It should be noted it is easier to remove the male luer cap in two steps, first, stabilize the cap, and then spin the luer collar one full turn, and pull back.Then, stabilize the collar in the grooves, and spin the luer while holding the cap.The cap should pop off.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: 60 IN NON-DEHP MINIBORE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24322458
• Report Number: 9616066-2026-00323
• Device Sequence Number: 13180187
• Product Code: FPA
• UDI-Device Identifier: 10885403236235
• UDI-Public: (01)10885403236235(17)300901(10)25095111
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 02/24/2026

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: Health Professional
• Device Catalogue Number: ME2010
• Device Lot Number: 25095111
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown