MAUDE Adverse Event Report: ICU MEDICAL TRIFUSE EXTENSION SET; STOPCOCK, I.V. SET

Model Number A1254

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 03/03/2021

Event Type  malfunction  

Event Description

Rn looking into a defective 0.2 micron filter, the sample left still had the trifuse (icu medical ref a1254) attached to it and one port was taped off and marked "do not use" one clave on the trifuse was stuck in the depressed/open position.Lot number unavailable, number provided below was from current stock on hand at the time of the event.Contacted rns involved to clarify appropriate process for removal of defective products immediately.Manufacturer contacted and device is being returned.Device is icu medical ref a1254.There was no detectable harm.

• Brand Name: TRIFUSE EXTENSION SET
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 11567682
• MDR Text Key: 242187940
• Report Number: 11567682
• 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: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A1254
• Device Lot Number: 5054318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA