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

Model Number 8888266122

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2017

Event Type  malfunction  

Event Description

The customer states that the tube was placed and the tube developed what appeared to be a hole.The tube was making a gurgling sound.When tube was flushed, the patient reported being able to feel the fluid in her throat.A doctor was notified.This led to increased pain, nausea, and distended abdomen.

Manufacturer Narrative

One decontaminated sample without original package or lot number was received for evaluation.After performing visual inspection, the condition reported was not confirmed.A review of the device history record could not be conducted because a lot number was not provided.The failure mode could not be confirmed.Therefore, the root cause was not identified for this incident.No corrective actions were deemed necessary at this time.The current process is running according to product specifications meeting quality acceptance criteria.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SALEM SUMP
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; no. 125 cuidad; tijuana,na 92173 ; MX 92173
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; no. 125 cuidad; tijuana,na 92173 ; MX 92173
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6421240
• MDR Text Key: 70748022
• Report Number: 9612030-2017-05041
• Device Sequence Number: 1
• Product Code: FEG
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888266122
• Device Catalogue Number: 8888266122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1