MAUDE Adverse Event Report: CARDIOMED SUPPLIES, INC. THERASAFE PHLEBOTOMY BAG W/NEEDLELESS Y ADAPTER & 17GX1" NEE; SET, I.V. FLUID TRANSFER

Catalog Number CM-TS17X1BH

Device Problems Leak/Splash (1354); Material Separation (1562)

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

Event Date 08/07/2014

Event Type  malfunction  

Event Description

Employee was completing a therapeutic phlebotomy on a patient at which time i noticed that the tubing on the blood collection set was leaking.Upon finishing the phlebotomy, the tubing on the blood collection set came completely apart allowing the blood to leak and run onto the floor.Rn placed the blood collection set into a biohazard sharps container and called environmental services (evs) who came to clean up the blood spill.

• Brand Name: THERASAFE PHLEBOTOMY BAG W/NEEDLELESS Y ADAPTER & 17GX1" NEE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): CARDIOMED SUPPLIES, INC.; 199 st. david street; lindsay * ; CA *
• MDR Report Key: 4023146
• MDR Text Key: 21809766
• Report Number: 4023146
• Device Sequence Number: 1
• Product Code: LHI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: CM-TS17X1BH
• Device Lot Number: G3113-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2014
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1