MAUDE Adverse Event Report: C. R. BARD, INC. GROSHONG 3 FR SINGLE-LUMEN PICC CATHETER, FULL PROCEDURE SAF; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 7717307

Device Problems Difficult to Flush (1251); Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

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

Event Date 10/18/2014

Event Type  malfunction  

Event Description

Picc line inserted without difficulty and fully functional.Three days later, the line would not flush and required repair.This facility has had multiple patients with this device and who are experiencing the same type of problem: the device is occluding and requiring repair at a higher rate than expected.The problem has been occurring over approximately 4 consecutive months.Only the 3 french size lines are affected.There are no similar patient common denominators and the type of fluids/medications given through the line varies by patient.The staff are following the manufacturer's instructions for flushing and caring for the lines.When patients with this device have occluded lines that cannot be repaired, a new line placement is required in order to continue therapy.The manufacturer has been notified with each event.The hospital is still waiting for the manufacturer to respond.

• Brand Name: GROSHONG 3 FR SINGLE-LUMEN PICC CATHETER, FULL PROCEDURE SAF
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C. R. BARD, INC.; 605 n 5600 w; salt lake city UT 84116
• MDR Report Key: 4272277
• MDR Text Key: 21973283
• Report Number: 4272277
• Device Sequence Number: 1
• Product Code: LJT
• 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: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 7717307
• Device Lot Number: REYG0435
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2014
• Patient Sequence Number: 1
• Patient Weight: 8