MAUDE Adverse Event Report: ICU MEDICAL, INC. SMALLBORE ICU MEDICAL; STOPCOCK, I.V. SET

Device Problems Break (1069); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 12/09/2020

Event Type  malfunction  

Event Description

While connecting new tubing to the "gang" connecter administering continuous infusions through the r dl ij, one separate port of the "gang" broke off.The continuous infusions needed to be paused and a new line setup was necessary.Patient required these medications for bp control and sedation prior to potential extubation.This could have been very harmful to the patient.This product was defective, i don't know how this could have been prevented.

• Brand Name: SMALLBORE ICU MEDICAL
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 11107816
• MDR Text Key: 224757372
• Report Number: 11107816
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2020

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 300 DA