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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP SALEM SUMP TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

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COVIDIEN LP SALEM SUMP TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION Back to Search Results
Model Number 266148
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2017
Event Type  malfunction  
Event Description
Nurse clamped ngt after administering crushed medications with the white end of the anti-reflux valve inserted into the blue sump part of the ngt. When nurse went to unclamp the ngt, the white part broke off of the blue end of the valve and remained stuck inside the clear portion of the ngt. It took over 10 minutes to dig the stuck part back out.
 
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Brand NameSALEM SUMP
Type of DeviceTUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
Manufacturer (Section D)
COVIDIEN LP
15 hampshire st.
mansfield MA 02048
MDR Report Key6263277
MDR Text Key65245101
Report Number6263277
Device Sequence Number1
Product Code FEG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number266148
Device Catalogue Number266148
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/18/2017
Event Location Hospital
Date Report to Manufacturer01/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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