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

Catalog Number PMA010A

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2016

Event Type  malfunction  

Event Description

Attempted to move painbuster catheter after a total knee and catheter tip broke off inside of pt's knee/surrounding tissue.Pt had to be brought back into operating room for removal of retained catheter tip.

• Brand Name: ON-Q SILVERSOAKER ANTIMICROBIAL CATHETER
• Type of Device: ON-Q SILVERSOAKER ANTIMICROBIAL CATHETER
• Manufacturer (Section D): I-FLOW
• MDR Report Key: 6157953
• MDR Text Key: 62123977
• Report Number: MW5066612
• Device Sequence Number: 1
• Product Code: BSO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2016

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: Health Professional
• Device Catalogue Number: PMA010A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 121