MAUDE Adverse Event Report: ICU MEDICAL, INC. SPINNING SPIROS CLOSED MALE LUER; CLOSED SYSTEM TRANSFER DEVICE

Lot Number 3774137

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 09/04/2018

Event Type  malfunction  

Event Description

Closed system transfer device spiros which is attached to intrathecal syringe, medication could not be pushed out of syringe during administration which caused delaying procedure.Inconsistent, sometimes device works and other times medications cannot be pushed out when it syringe is attached, this compromises patient safety and sterility of chemo medication.Reported to manufacturer about the issue.

• Brand Name: SPINNING SPIROS CLOSED MALE LUER
• Type of Device: CLOSED SYSTEM TRANSFER DEVICE
• Manufacturer (Section D): ICU MEDICAL, INC.; san clemente CA 92673
• MDR Report Key: 7978937
• MDR Text Key: 124791046
• Report Number: MW5080642
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3774137
• Was Device Available for Evaluation?: No
• 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
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 72