MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 5 CLAMPS (3 WHITE, 1 BLUE, 1 RED), R; STOPCOCK, I.V. SET

Catalog Number MC330360

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2023

Event Type  malfunction  

Event Description

The event involved a 10" quadfuse ext set w/4 microclave® clear, 5 clamps (3 white, 1 blue, 1 red), rotating luer.The reporter stated that they had a broken quad fuse where the tubing that connects to patient side came out of the luer-lock housing that goes into the patient¿s microclave cap at on his central venous catheter.It was reported that the broken tubing was found after it was connected to patient for several hours.The tubing slid out of the housing that has luer lock.Luer lock remained in patient¿s cap keeping cap engaged while quadfuse was detached entirely from patient.Infusing medication while connect to patient; the device fell off and leaked multiple medications.The customer also reported 'small blood (no estimate of blood loss) loss from patient.' there was patient involvement; no harm was reported as a consequence of this event.

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is not yet received.E1 - additional contact phone number: (b)(6).

Manufacturer Narrative

One (1) photo was shared by the customer, where there is missing from the end of the tubing the male luer from the item #mc330360.The item is placed over a white surface which looks to be wet.One (1) used sample #mc330360 was received 11/21/23 connected to an unknown chemolock port.As received it was noted that the male luer was missing from the end of the tubing on the sample.The missing male lues was not returned for evaluation.The tube was analyzed through uv light and it was confirmed not presence of solvent on tube.The tube was measured and it was found within specification.Complaint of leaks can be confirmed based on the used physical sample evaluation and the photo shared by customer.The probable cause was due to insufficient solvent applied during manual process assembly in manufacturing.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 10" QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 5 CLAMPS (3 WHITE, 1 BLUE, 1 RED), R
• 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: 18055924
• MDR Text Key: 327170431
• Report Number: 9617594-2023-00928
• 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,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC330360
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: NORMAL SALINE, MFR UNK.; TACROLIMUS, MFR UNK.