MAUDE Adverse Event Report: I-FLOW CORP I-FLOW ON-Q SILVERSOAKER CATHETER; ON-Q CATHETER

Lot Number 0200989916

Device Problems Break (1069); Device, or device fragments remain in patient (1527); Tip breakage (1638)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

According to staff, pt was receiving pain management therapy via an on-q pain ball with catheter in the left lateral back and left anterior chest sites.During assessment of pt, rn noted that the left anterior catheter was broken.Notified pa who removed subcutaneous catheter.Observed small piece of catheter was left under the skin.Physician and on-q pain representative notified.Chest x-ray done which confirmed catheter under skin.

• Brand Name: I-FLOW ON-Q SILVERSOAKER CATHETER
• Type of Device: ON-Q CATHETER
• Manufacturer (Section D): I-FLOW CORP; 20202 windrow drive; lake forest CA 92630
• MDR Report Key: 4396040
• MDR Text Key: 5122226
• Report Number: 4396040
• Device Sequence Number: 1
• Product Code: BSO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0200989916
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/12/2014
• Event Location: Other
• Date Report to Manufacturer: 12/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 40