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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL DRAIN
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SURGICAL DRAIN Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problems Hemorrhage/Bleeding (1888); Device Embedded In Tissue or Plaque (3165)
Event Date 01/17/2018
Event Type  Injury  
Event Description
A (b)(6) year old male with degenerative joint disease, underwent left total knee replacement.Post op orders were entered for a surgical drain, including to remove the drain the next day, and the patient was discharged on day 2.Three days later the patient presented to the emergency department for bleeding from the incision.Work up did not identify any acute problems and the patient was discharged.At an ortho office visit, an x-ray identified a retained foreign body and the patient returned for surgery to remove a segment of a surgical drain.The patient was discharged to home later that day.Event investigated by clinical managers and referred to nursing peer review from perspective of removal on surgical unit as well as initiating line/drain/airway entry into the medical record in the operating room.Referrals also made to surgical peer review for documentation concerns and to ed and radiology peer review for the missed retained foreign body.
 
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Brand Name
SURGICAL DRAIN
Type of Device
SURGICAL DRAIN
MDR Report Key7317054
MDR Text Key101711720
Report NumberMW5075709
Device Sequence Number1
Product Code GBP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 03/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age76 YR
Patient Weight89
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