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U.S. Department of Health and Human Services

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

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CARDINAL HEALTH SALEM SUMP W/ ARV 16FR. 48IN TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION Back to Search Results
Model Number 8888266130
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/08/2021
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
Customer reports: the anti-reflux valve on patient oral gastric tube. The white end connected to oral gastric tube to clamp off system during transport to mri. On return from mri, when attempting to disconnect white end from oral gastric drain end white piece broke off from valve system and remained in oral gastric tube. Could not remove white end despite attempt to pry out of tube. Oral gastric tube removed. New nasogastric tube inserted.
 
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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)
CARDINAL HEALTH
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX 22500
Manufacturer (Section G)
CARDINAL HEALTH
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX 22500
Manufacturer Contact
jill saraiva
777 west street
mansfield, MA 02048
5086183640
MDR Report Key12632007
MDR Text Key276383444
Report Number9612030-2021-03061
Device Sequence Number1
Product Code FEG
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 10/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888266130
Device Catalogue Number8888266130
Device Lot Number2117345564
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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