MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING; STOPCOCK, I.V. SET

Catalog Number	MC3302
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 7" (18 cm) appx 0.24 ml, smallbore ext set w/microclave® clear, clamp, rotating luer was found to have a crack leading to a blood leak during patient use.The report stated that the microclave of the fused extension piece was noted to crack causing blood to leak.Peripheral arterial line (pal) being inserted by acts team.It was recognized immediately, and the extension piece was switched out.This has been an issue where there is an internal bore malfunction that allows for fluid to leak within the cap.They have the extension piece and the packaging, but it is heavily soiled with this patient's blood given that it was used as a part of an arterial access insertion.There was no patient harm reported.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
Received one used mc3302 smallbore ext set w/microclave for inspection.As received, there was internal leakage on the microclave.The set was leak tested per product specifications.There was internal leakage on the microclave.The microclave was disassembled and a cut on the top surface and side wall of the seal was found, typical of a needle strike.The housing had gouges on the side wall.The reported complaint can be confirmed.The probable cause of the damage and subsequent leakage is due to access with a needle.The directions for use (dfu) states: do not use needles.The device history lot number was reviewed, and no relevant non-conformities were found that would have led to the reported complaint.Updated information in b5 and d9.
Event or Problem Description
Additional information received on 10-feb-2025 stating that, the microclave fused cap extension piece was primed prior to attaching it to the arterial catheter after insertion.It was then used to draw a blood sample using a luer lock syringe.No complications were noted when drawing the sample.However, when the flush was attached to clear the blood in the extension piece, leaking was noted in the hub and at the connection between the fused cap and the bore of the tubing.No deviation from standard line practices were identified.The extension set was attached to the iv catheter on one end and two syringes were attached and removed via the luer mechanism on the cap end prior to the defect being identified.No harm to the infant as the defect was noticed immediately.

• Brand Name: 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING
• Common Device Name: STOPCOCK, I.V. SET
• 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: 21541020
• Report Number: 9617594-2025-00412
• Device Sequence Number: 12546295
• Product Code: FMG
• UDI-Device Identifier: 00887709037267
• UDI-Public: (01)00887709037267(17)290801(10)14118710
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• 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): 04/07/2025

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: MC3302
• Device Lot Number: 14118710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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: ARTERIAL LINE CATHETER, UNK MFR; LUER LOCK SYRINGE, UNK MFR
• Patient Sex: Unknown