MAUDE Adverse Event Report: C.R. BARD, INC. NASOGASTRIC SUMP TUBE W/PREVENT ANTI-REFLEUX FILTER; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number 0046160

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 08/30/2018

Event Type  malfunction  

Event Description

Ng tube had been placed for gastric decompression.Rn attempted to administer ct contrast through ng and noted fluid and gastric contents leaking onto patient's gown.Upon examination of ng tube it was found that where the blue ant-reflux tube exited the clear portion of the ng tube that there was an opening that was allowing the escape of fluids being instilled/drained.Enteric tube had to be removed and another ng tube was placed.Manufacturer response for nasogastric sump tube with prevent anti-reflux filter, (brand not provided) (per site reporter).I spoke to bard quality issues.They are sending me shipping material.

• Brand Name: NASOGASTRIC SUMP TUBE W/PREVENT ANTI-REFLEUX FILTER
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 7913745
• MDR Text Key: 121864973
• Report Number: 7913745
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0046160
• Device Catalogue Number: 0046160
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18980 DA
• Patient Weight: 124