MAUDE Adverse Event Report: COVIDIEN LLC GASTROINTESTINAL TUBE AND ACCESSORIES; SALEM SUMP DUAL LUMEN STOMACH TUBE

Lot Number 529503964X

Device Problems Break (1069); Coiled (1098); Difficult to Advance (2920)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/30/2017

Event Type  malfunction  

Event Description

On (b)(6) 2017, this pt needed an oral gastric tube (ogt) placed.This was approx the 3rd ogt he has needed during his current hospital stay.The nurse was unable to get an ogt placed during day shift as it kept coiling in his mouth.The nurse obtained a 12 french covidien salem sump dual lumen stomach tube, but was also unsuccessfully for the same reason.The nurse then placed the tube in a cup of ice water at approx 1845 and reported to the night nurse about the events/attempts and that the tube was in some ice water to "stiffen up" and hopefully she would be able to get it placed successfully.At approx 2030 the night nurse placed the ogt easily without any issue or resistance, auscultated for placement, and obtained an x-ray to confirm placement.The x-ray showed that the ogt was in the pt's lung.The ogt was removed at 2239 without incident and appearing intact upon removal and was discarded into the trash.Later in the day, on (b)(6) 2017, the pt required a bronchoscopy due to his illness and disease process.During the bronchoscopy, the physician found a 4cm piece of an ogt in pt's lung.It was removed without incident.(ref # (b)(4)).

• Brand Name: GASTROINTESTINAL TUBE AND ACCESSORIES
• Type of Device: SALEM SUMP DUAL LUMEN STOMACH TUBE
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 6803313
• MDR Text Key: 83154589
• Report Number: MW5071667
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/03/2017

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: Health Professional
• Device Lot Number: 529503964X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR