MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" SMALLBORE PRESSURE INFUSION (400PSIG) BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33257
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The event involved a 7" smallbore pressure infusion (400psig) bifuse ext set w/2 microclave® clear, 2 clamps, rotating luer.It was reported that when the clinician was attempting to disconnect the icu med y-tubing from a medline brand blood culture access device, the blood culture device snaped at the luer connection.This caused a hazardous needle stick for the clinician.The luer connection was so tight that even after the break, the parts remained stuck together.When discussed this event with the clinicians, it was noted that the y connecter is often very tight with multiple different types of tubing (icu med tubing), and they believe the contributing factor was how tight the y tubing connection is (though the luer lock connection on the blood culture access device shattering is obviously a concern as well).There was no harm to the patient but there was a delay in care as new consumables were sourced and the line clamped to continue the draw, but this did cause harm to the clinician, and both are of concern.There was no reported patient involvement.
Additional Manufacturer Narrative
The device is available for evaluation - it has not been received.The investigation is pending.
Event or Problem Description
Additional information was received stating that the clinician wound was cleaned with soap and water and employee followed up with employee health for blood draw for needlestick battery and no further treatment needed beyond that.There was a patient involvement with no reported harm.
Additional Manufacturer Narrative
The reported complaint of a tight connection could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed, and a probable cause cannot be determined.Updated information in d9.Corrected information in a and b tabs.Additional contact information: (b)(6).

• Brand Name: 7" SMALLBORE PRESSURE INFUSION (400PSIG) BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24957259
• Report Number: 9617594-2026-00395
• Device Sequence Number: 10029842
• Product Code: FPA
• UDI-Device Identifier: 00887709037557
• UDI-Public: (01)00887709037557(17)310201(10)14838789
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MC33257
• Device Lot Number: 14838789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLOOD CULTURE ACCESS, MEDLINE
• Patient Sex: Unknown