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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
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 where the customer reported that while completing iv starts on patient, the staff noted that several patient iv extension lines were leaking.That was a major problem, as all patients in pet/ct department and most in the nuclear medicine departments need the lines when injecting a radioactive pharmaceutical.There was patient involvement, but no adverse harm reported.
Additional Manufacturer Narrative
Received two used mc33150 smallbore pressure infusion ext sets for complaint investigation.No defects or anomalies noted.Functional: each set was leak-tested and there was no leakage identified.A test infusion was done with a high-pressure infuser up to 400 psig.There was internal leakage on the microclave but no functional failure.The customer's complaint was unable to be replicated or confirmed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in b6.

• 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: 21678476
• Report Number: 9617594-2025-00543
• Device Sequence Number: 20910745
• Product Code: FPA
• UDI-Device Identifier: 00887709037441
• UDI-Public: (01)00887709037441(17)290901(10)14126901
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 14126901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• 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: RADIOACTIVE PHARMACEUTICAL. MFR UNK
• Patient Sex: Unknown