MAUDE Adverse Event Report: ICUMEDICAL SPINNING SPIROS CLOSED MALE CAP

Model Number CH2000S-C

Device Problems Disconnection (1171); Chemical Spillage (2894); Device Operates Differently Than Expected (2913)

Patient Problem Chemical Exposure (2570)

Event Date 10/20/2017

Event Type  malfunction  

Event Description

A patient was being administered treatment when the iv tubing disconnected from the iv line in the patient's arm.This caused the running 5fu to spill on the patient's bed and bedsheets, which amounted to about 2-5 cc.The attending nurse and charge nurse connected the iv tubing to the spinning spiros cap.When they tested the tubing a second time, fluid spilled out of the spiros cap.The spiros cap did not prevent the chemo leak.

• Brand Name: SPINNING SPIROS CLOSED MALE CAP
• Type of Device: SPINNING SPIROS CLOSED MALE CAP
• Manufacturer (Section D): ICUMEDICAL; san clemente CA 92673
• MDR Report Key: 7037440
• MDR Text Key: 92474940
• Report Number: MW5073345
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: CH2000S-C
• Device Lot Number: 3433830
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1