MAUDE Adverse Event Report: ICU MEDICAL; ADAPTER, HYGIENE

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 05/05/2015

Event Type  malfunction  

Event Description

Staff was twisting the syringe of normal saline (ns) onto the vial adapter to reconstitute a 500 mg vial of alimta when the blue tip came off of the adapter, making it no longer a closed system.

• Type of Device: ADAPTER, HYGIENE
• Manufacturer (Section D): ICU MEDICAL; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 4861827
• MDR Text Key: 17215106
• Report Number: 4861827
• Device Sequence Number: 1
• Product Code: ILS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2015
• Patient Sequence Number: 1