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U.S. Department of Health and Human Services

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

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I-FLOW ON-Q SILVERSOAKER ANTIMICROBIAL CATHETER Back to Search Results
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.
 
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Brand Name
ON-Q SILVERSOAKER ANTIMICROBIAL CATHETER
Type of Device
ON-Q SILVERSOAKER ANTIMICROBIAL CATHETER
Manufacturer (Section D)
I-FLOW
MDR Report Key6157953
MDR Text Key62123977
Report NumberMW5066612
Device Sequence Number1
Product Code BSO
Reporter Country CodeUS
Number of Events Reported1
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 NumberPMA010A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/06/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age63 YR
Patient Weight121
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