Bard® Nasogastric Sump Tube 0042160Recalls & reported problems
C. R. Bard, Inc. · Bard® Nasogastric Sump Tube · Class 2
All models of Bard Nasogastric Sump Tube (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741052262), received between Apr 27, 2017 and Dec 17, 2025 — classified as 1 injury, 12 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn5
- Fluid/Blood Leak4
- Leak/Splash2
- Deflation Problem1
- Device Dislodged or Dislocated1
- Device Handling Problem1
- Device Markings/Labelling Problem1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
- Failure of Implant1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WAS A HOLE IN BOTH NASOGASTRIC TUBE CAUSED THEM TO LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23830157 ↗MalfunctionFeb 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE 16 FR NASOGASTRIC TUBE HAD A HOLE IN THE TUBING NEAR THE BLUE PORT. THIS WAS THE SECOND OR THIRD TIME THEY HAD NOTICED THIS ISSUE. THIS WAS AN ISSUE BECAUSE EVERY TIME TO FLUSH THE TUBE IT LEAKED; THEREFORE, THE PATIENT WAS NOT RECEIVING THEIR CORRECT DOSE OF MEDICATION. ALSO, THE TUBE FEEDINGS WERE LEAKING TOO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21387848 ↗MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT NURSES WERE HAVING DIFFICULTY UTILIZING THE BARD NASOGASTRIC SUMP TUBES. STATED THAT THEY WERE CONTINUOUSLY LEAKING EVEN WHEN PLACED ON SUCTION AND ALSO, AN ISSUE THAT THEY HAVE NOTED WAS THAT THE MARKINGS WERE NOT THE NORMAL CENTIMETERS (CM) MARKINGS AS WITH THE KANGAROO PRODUCT. WITH THAT BEING SAID NURSE DOCUMENT THE DEPTH OR LENGTH AT WHERE THE TUBE WAS PLACED. THEY ALSO WANT TO KNOW IF THE TUBES COULD BE USED FOR MEDICATION OR TUBE FEEDS AS WELL AS WHAT THE DIFFERENCE BETWEEN MARKING WERE ON BARD VERSES OTHER TUBES. PER SAMPLE FORM RECEIVED VIA EMAIL ON 30APR2024, IT WAS REPORTED THAT THE BARD NASOGASTRIC SUMP TUBES WOULD LEAK WITH SUCTION AND FEEDINGS, NURSING UNABLE TO PROVIDE ACCURATE LOSS, NOT ENOUGH MARKINGS TO DETERMINE TUBE PLACEMENT FROM SHIFT TO SHIFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19039951 ↗MalfunctionMar 17, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE 16 FRENCH BARD NASOGASTRIC SUMP TUBE WAS PLACED AND ATTEMPTED TO AUSCULTATE AIR IN THE BELLY. AT THAT POINT, WHEN PLACED TO SUCTION, THE CAREGIVERS NOTED A SMALL HOLE IN THE TUBING NEAR THE EXHAUST PIPE WHERE JUNCTION OF TUBE AT DISTAL SIDE FROM PATIENT. AS PER FOLLOW UP VIA EMAIL ON (B)(6) 2023, IT WAS REPORTED THAT THE LOT FOR THE DEVICE WAS NGGS1366. THERE WAS NO PATIENT IMPACT AND THE DEVICE WAS DISPOSED OF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16564749 ↗MalfunctionDec 29, 2022Fluid/Blood Leak; Device Handling Problem; Fluid/Blood Leak; Device Handling Problem
IT WAS REPORTED THAT THE NASOGASTRIC TUBE WAS LEAKING. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 21-DEC-2022, IT WAS REPORTED THAT THE CUSTOMER HAD USED THE CONNECTION THAT WAS NOT INDICATED TO BD. IT WAS ALSO STATED THAT THEY HAD BEEN HOOKING IT UP TO A FEEDING ADMINISTRATION SET FOR CONTINUOUS FEED WHICH WAS NOT BD NG TUBES. REPRESENTATIVE REVIEWED THE INDICATIONS THAT WERE SHORT WERE SHORT FROM FEED AND SUGGESTED THAT THE CUSTOMER NEEDED A CONNECTION WHICH ALLOWS FOR THE SUCTION TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16068640 ↗MalfunctionJun 15, 2022Fluid/Blood Leak; Nonstandard Device; Fluid/Blood Leak; Nonstandard Device
IT WAS REPORTED THAT THE MEDICATIONS AND TUBE FEEDS GIVEN THROUGH THE NASOGASTRIC TUBE WERE NOT RECEIVED BY THE PATIENT DUE TO FAULTY EQUIPMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14695344 ↗MalfunctionMay 20, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
IT WAS REPORTED THAT THE NASOGASTRIC TUBE WAS LEAKING AT THE CONNECTION OF SUMP PORT TO TUBE. THE CUSTOMER STATED THAT THE TUBE WAS REMOVED AND REPLACED AND REQUIRED TO X-RAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14453969 ↗MalfunctionOct 12, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE NASOGASTRIC TUBE WAS UNABLE TO SUCTION AND THERE APPEARED TO BE A HOLE IN THE TUBE JUST AT THE AIR VENT PORT CONNECTION. PER FORM RECEIVED WITH RETURN SAMPLE ON 19NOV2021, IT WAS STATED THAT THE (OG) TUBE PLACED AND WHEN ATTEMPTED TO BLOW PATIENT WITH AIR TO WILY PLACEMENT AND X-RAY THE HOLE WAS NOTED IN THE TUBE AND THE TUBE WAS REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12615931 ↗MalfunctionJun 23, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE NURSE WAS ATTEMPTING TO ADMINISTER A MEDICATION INTO AN OROGASTRIC TUBE WHICH WAS PLACED BY THE DOCTOR AND CONFIRMED BY X RAY. WHEN THE NURSE WOULD ATTEMPT TO INFUSE THE MEDICATION INTO THE CORRECT PORT THE MEDICATION WOULD SPRAY OUT OF A HOLE IN THE OROGASTRIC TUBE NEAR THE CONNECTION OF THE BLUE AIR PORT TO THE OROGASTRIC TUBE. THE DOCTOR WAS NOTIFIED OF THE DEFECT IN THE OROGASTRIC TUBE. THE TUBE WAS REMOVED AND A NEW OROGASTRIC TUBE WAS PLACED AND A NEW X RAY TO CONFIRM THE PLACEMENT WAS ORDERED AND PERFORMED ON THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2021 IT WAS STATED THAT THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12050103 ↗MalfunctionJul 12, 2019Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE NO NUMBERS ON THE CENTIMETER MARKINGS ON THE TUBE, MAKING IT DIFFICULT TO QUICKLY SEE AND ASSESS IF THE TUBE BECOMES DISLODGED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8785811 ↗MalfunctionSep 20, 2018Leak/Splash; Gas/Air Leak; Pressure Problem; Leak/Splash
IT WAS REPORTED THAT THERE WAS AIR PRESSURE BUILD UP NEAR THE BLUE VENT PORT OF THE DEVICE THAT CONNECTS TO THE CLEAR TUBING; THEREFORE, THE PATIENT'S CONTENTS WERE PUSHING BACK THROUGH AND LEAKING FROM THE TUBING. THERE WAS NO MEDICAL INTERVENTION REPORTED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7894807 ↗MalfunctionMay 26, 2017Leak/Splash
IT WAS REPORTED THAT THE DEVICE LEAKED FROM THE BLUE PORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6593573 ↗InjuryApr 27, 2017Deflation Problem; Device Dislodged or Dislocated; Material Integrity Problem
IT WAS REPORTED THAT AFTER THE NASOGASTRIC (NG) TUBE WAS PLACED, THE PATIENT WENT HOME AND THE NG TUBE BECAME DISLODGED THE DAY AFTER. THE PATIENT ALLEGEDLY WENT BACK TO THE HOSPITAL TO HAVE AN ADDITIONAL SURGERY TO REPLACE THE NG TUBE. THE ATTENDING PHYSICIAN BELIEVED THAT THE PORTION OF THE BALLOON WHERE THERE WAS GLUE SEEMED AS IF IT HAD PEELED OFF AND FLIPPED ON ITSELF; DEFLATING THE BALLOON AND CAUSING IT TO FALL OUT.
Patient problems: Failure of Implant
MAUDE report 6526861 ↗
Other TUBE, NASOGASTRIC devices
- Bard® Nasogastric Sump Tube with Enfit™ EN0042140C. R. Bard, Inc. · TUBE, NASOGASTRIC1 recall4 reports
- Bard® Nasogastric Sump Tube with Enfit™ EN0042120C. R. Bard, Inc. · TUBE, NASOGASTRIC1 recall2 reports
- Bard® Nasogastric Sump Tube with Enfit™ EN0042160C. R. Bard, Inc. · TUBE, NASOGASTRIC1 recall2 reports
- Bard® Nasogastric Sump Tube with Enfit™ EN0042180C. R. Bard, Inc. · TUBE, NASOGASTRIC1 recall2 reports
- Bard® Nasogastric Sump Tube with Enfit™ EN0042100C. R. Bard, Inc. · TUBE, NASOGASTRIC1 recall0 reports
- ENFit PU Feeding Tube PFTM5.0P-NCAvanos Medical, Inc. · TUBE, NASOGASTRIC10 reports
- ENFit PU Feeding Tube PFTL6.5P-NCAvanos Medical, Inc. · TUBE, NASOGASTRIC8 reports
- Bard® Nasogastric Sump Tube 0042140C. R. Bard, Inc. · TUBE, NASOGASTRIC7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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