MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 3 CHECK VALVES, 4 CLAMPS (3; STOPCOCK, I.V. SET

Catalog Number MC33688

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it has not yet been received.

Event Description

The event occurred on an unspecified date and involved a 4" smallbore quadfuse ext set w/4 microclave® clear, 3 check valves, 4 clamps (3 white, red), rotating luer.The customer reported that the patient was unstable and was on multiple inotropes which was running in the right internal jugular vein (rij) via a quadfuse.There was a blue pad near the head of the bed that was noted to be wet.The customer stated that upon examination it was noted that the quadfuse was severed and leaking.The line was running vasopressin, norepinephrine and epinephrine.The quadfuse was switched out quickly and infusion resumed.There was patient involvement but harm was not reported as a consequence of the event.

Manufacturer Narrative

One (1) photo was shared by the customer, where one tube of the set is observed to be torn.However, no drops of leaks are observed on the photos.One (1) used sample #(b)(4) was returned for evaluation 2/23/24.As received internal fluid was observed inside and the tube of one of the lines was cut.This would suggest that the line was cut during use.No additional damage or anomalies were observed.Complaint of leaks can be confirmed based on the cut observed.Based on the internal fluid inside the set, this condition happened during use.However, probable cause cannot be determined.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 3 CHECK VALVES, 4 CLAMPS (3
• 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: 18744081
• MDR Text Key: 335854732
• Report Number: 9617594-2024-00171
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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: MC33688
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EPINEPHRINE, MFR UNK; NOREPINEPHRINE, MFR UNK; VASOPRESSIN, MFR UNK