MAUDE Adverse Event Report: C.R. BARD, INC POWERLOC SAFETY INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 0651910

Device Problems Fluid/Blood Leak (1250); Moisture Damage (1405); Cut In Material (2454); Split (2537)

Patient Problem No Information (3190)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

Patient called staff to the room.Bed soaked with iv fluid, iv leaking as tubing was split/cut (not a connection).Both ends of tubing touching the bed linens and patient, thus exposing a central line to possible bacteria and germs.Patient is neutropenic as has received chemotherapy recently.Portacath de-accessed and re-accessed with new tubing and needle.Previous needle with tubing saved.Patient was alert.The two nurse coordinators for the general medical unit(gmu) said that if it was torn, it would have been jagged.The tubing looked like it had a straight cut.When i asked the gmu nurses if this has ever happen before, one of them stated that sometimes the tubing comes loose and she just pushes it back in.Slit is small (approx 1/4 inch long) and near the last inch of the tubing.

• Brand Name: POWERLOC SAFETY INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 4011932
• MDR Text Key: 20270464
• Report Number: 4011932
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 0651910
• Device Catalogue Number: 0651910
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2014
• Patient Sequence Number: 1
• Treatment: IMMUNOTHERAPY
• Patient Age: 86 YR