MAUDE Adverse Event Report: ICU MEDICAL, INC. SPINNING SPIROS, CLOSED MALE LUER CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number CH2000SC-10

Device Problems Fluid Leak (1250); Physical Resistance/Sticking (4012)

Patient Problem Chemical Exposure (2570)

Event Date 02/03/2021

Event Type  malfunction  

Event Description

Patient was receiving vidaza injection with closed-system transfer device attached to the end of the syringe. Nurse met resistance with vidaza and while attempting to push the drug, vidaza sprayed out of the closed-system transfer device spraying onto nurse and patient.

• Brand Name: SPINNING SPIROS, CLOSED MALE LUER
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 11313183
• MDR Text Key: 231370472
• Report Number: 11313183
• Device Sequence Number: 1
• Product Code: ONB
• 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: 02/04/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CH2000SC-10
• Device Lot Number: 5021931
• 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: 02/04/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/11/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown