MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20 CM) APPX 0.49 ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING; STOPCOCK, I.V. SET

Catalog Number B1434

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

The complaint of leaks on item (b)(4) cannot be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The device history review (dhr) couldn't be performed because the lot number for this complaint was unknown.

Event Description

It was reported that an 8" (20 cm) appx 0.49 ml, smallbore ext set w/0.2 micron filter, clamp, rotating luer generated a leak during patient use.The report states that the product was leaking fluids.Upon infusion, the registered nurse (rn) noticed some leaking from the gub connection between the nicotinamide adenine dinucleotide (nad) and pressure disc tubing.Multiple items were being reported as failing to split cifs for each vendor - items were pressure disc tubing and cardiac filter, microclave.There was patient involvement and no human harm was reported.

• Brand Name: 8" (20 CM) APPX 0.49 ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING
• Type of Device: 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: 19043365
• MDR Text Key: 340130324
• Report Number: 9617594-2024-00369
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/04/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: B1434
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED FLUID, UNK MFR