MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAV; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33150
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 7" (18cm) appx 0.24ml, smallbore pressure infusion (400psig) ext set w/microclave® clear, purple clamp, rotating luer.The reporter stated that they went to hang new dose of blina at 1815 on an iv, not a port.Upon unhooking the bifuse, they noticed that blood started back priming from iv.Since they're not supposed to flush blina, they just connected the tubing to the iv and started the blina.The blood cleared from the line.At 1900, pt called and told that the tubing just started leaking.They called the iv team to come immediately to look at the iv.Since they got great blood return, they didn't want to place a new iv, but they changed the iv tubing.They found that the clave attached to the iv tubing was cracked.They didn't flush any blina but only got a new tubing to connect to the old iv then flushed with the new saline line.The blina was paused from 1900-1915 when iv got there.There was patient involvement; however, there was vno adverse event.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
Investigation summary received one (1) used mc33150 smallbore pressure infusion ext set for inspection.The microclave was stuck down as received.No mating devices were returned for inspection.The set was leak tested per product specifications.There was leakage from the microclave.The microclave was disassembled and the internal spike was found to be bent and broken.The reported complaint can be confirmed.The directions for use states: the clave connector is compatible with luers with an internal diameter (id) between.062 inch and.110 inch.A device history review could not be conducted because no lot number(s) was/were identified.Probable cause is related to the manufacturing process.

• Brand Name: 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAV
• 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: 22502186
• Report Number: 9617594-2025-01448
• Device Sequence Number: 8476826
• Product Code: FPA
• UDI-Device Identifier: 00887709037441
• UDI-Public: 00887709037441
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: Health Professional
• Device Catalogue Number: MC33150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: BLINA, MFR UNK.; SALINE SOLUTION LINE, MFR UNK.; UNSPECIFIED INFUSION BAG, MFR UNK.; UNSPECIFIED IV PRIMARY TUBING, MFR UNK.
• Patient Sex: Unknown