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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SALEM SUMP W/ ARV 16FR. 48IN TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

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COVIDIEN SALEM SUMP W/ ARV 16FR. 48IN TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION Back to Search Results
Model Number 8888266130
Device Problem Fluid Leak (1250)
Patient Problem Feeding Problem (1850)
Event Date 03/17/2021
Event Type  malfunction  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.   as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.   if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
The customer reported that the patient had an ogt in place with tube feeds infusing when they noticed that the tube feeds were leaking in the bed. Upon looking for a source of the leak, they found that there was a small hole in the og tubing located at the bifurcation of the small blue vent tubing where it connects to the tube itself. They taped over the bifurcation hoping to stop the leak before ultimately having to replace the entire og tube. However, the new og tube that was placed was also leaking from the exact same location. This was causing the patient to not receive all of the ordered tube feeds and water flushes as they leak out, soaking the patient's gown, sheets, etc. There was no patient injury reported.
 
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Brand NameSALEM SUMP W/ ARV 16FR. 48IN
Type of DeviceTUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX 22500
Manufacturer (Section G)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX 22500
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key11562491
MDR Text Key243525556
Report Number9612030-2021-02825
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 Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 03/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888266130
Device Catalogue Number8888266130
Device Lot Number2019103064
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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