MAUDE Adverse Event Report: EQUASHIELD LLC CSTD FC-1 ADAPTOR; IV TRANSFER SET

Catalog Number FC-1

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2016

Event Type  malfunction  

Event Description

When demonstrating how to use the equashield adaptors, disconnected the two adaptors and noticed a drop of chemotherapy at the top of the rubber diaphragm of the ll1 equashield adaptor.

• Brand Name: CSTD FC-1 ADAPTOR
• Type of Device: IV TRANSFER SET
• Manufacturer (Section D): EQUASHIELD LLC; 99 seaview blvd.; port washington NY 11050
• MDR Report Key: 6209045
• MDR Text Key: 63412053
• Report Number: 6209045
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/01/2019
• Device Catalogue Number: FC-1
• Device Lot Number: 16-20129
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1