MAUDE Adverse Event Report: ICU MEDICAL, INC. SPINNING SPIROS CLOSED MALE LUER; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Defective Device (2588); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spinning spiros closed male luer, red cap was defective as unable to administer medication through the luer.

• Brand Name: SPINNING SPIROS CLOSED MALE LUER
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.
• MDR Report Key: 16789327
• MDR Text Key: 313826933
• Report Number: MW5116885
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/17/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male