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

Model Number 8888266130

Device Problem Fluid/Blood 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.

• Brand Name: SALEM SUMP W/ ARV 16FR. 48IN
• Type of Device: TUBE, 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 Key: 11562491
• MDR Text Key: 243525556
• Report Number: 9612030-2021-02825
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 10884521004719
• UDI-Public: 10884521004719
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2021

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: No Information
• Device Model Number: 8888266130
• Device Catalogue Number: 8888266130
• Device Lot Number: 2019103064
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 03/24/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1