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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.
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 generated a leak during patient use.The reporter stated that the patient was receiving intravenous abdomen (iv abd) via a syringe pump when the antibiotics (abx) dose was completed, the writer went in to start flushing and noticed a small amount of blood on the sheet around the hub of the syringe pump tubing and peripheral intravenous catheter (piv).Staff tried to tighten same and was already tight.Blood was still dripping out at the back of the lure lock assembly.The sample is not available for evaluation.There was patient involvement and no adverse event.
Additional Manufacturer Narrative
One used list #unknown extension set was received for inspection on 4/11/2025.As received, the tubing was separated from the distal male luer.The tubing had been inserted into the bond pocket but was no longer bonded.Evaluation of the bond area showed little to no solvent.The reported complaint of leakage can be confirmed due to the separation.The probable cause of the separation is due to insufficient solvent applied during manual assembly in manufacturing.Lot history review could not be reviewed due to the unknown lot number.Additional information d9.

• 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: 21585445
• Report Number: 9617594-2025-00457
• Device Sequence Number: 8833273
• Product Code: FMG
• UDI-Device Identifier: 00887709037267
• UDI-Public: 00887709037267
• 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): 06/17/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 06/17/2025
• 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
• Patient Sex: Unknown