MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® NASOGASTRIC SUMP TUBE AND PREVENT® FILTER AND LOPEZ VALVE® WITH ENFIT¿

Catalog Number	EN0056160
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the currently stocked bard sump nasogastric tubes were not draining appropriately when connected to suction drainage.Customer was told of up to 4 instances where the tube had to be replaced shortly after being placed due to clogging or not draining.This resulted in delays in care for their patient (i.E.Drainage of stomach contents), and dissatisfaction with multiple invasive procedures to replace tubes, not to mention the additional x-rays exposure required to verify tube placement.Compared to the covidien ng salem sump tubes customer had been using, the size of the hole to allow drainage from suction was significantly smaller in the bard.They were concerned about the repeated invasive procedure that can cause trauma, discomfort, patient dissatisfaction and repeated exposure to radiation.There was another set of staff with the same concerns.Customer had multiple areas expressed concerns with the bard sub for the nasogastric tubes.Customer thought the bard tube should be pulled from use immediately.Per additional information received via email on 14dec2023, it was reported that the nasogastric tube having issues with clogging as they used suction.Stated that to add the adaptor caused the tubing to narrow and this was a huge safety concern.Per additional information received via email on 15dec2023, it was reported that a deidentified snapshot of an x-ray taken at 12:30 morning of a markedly non-functioning nasogastric and confirmed it was the bard tube.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the currently stocked bard sump nasogastric tubes were not draining appropriately when connected to suction drainage.Customer was told of up to 4 instances where the tube had to be replaced shortly after being placed due to clogging or not draining.This resulted in delays in care for their patient (i.E.Drainage of stomach contents), and dissatisfaction with multiple invasive procedures to replace tubes, not to mention the additional x-rays exposure required to verify tube placement.Compared to the covidien ng salem sump tubes customer had been using, the size of the hole to allow drainage from suction was significantly smaller in the bard.They were concerned about the repeated invasive procedure that can cause trauma, discomfort, patient dissatisfaction and repeated exposure to radiation.There was another set of staff with the same concerns.Customer had multiple areas expressed concerns with the bard sub for the nasogastric tubes.Customer thought the bard tube should be pulled from use immediately.Per additional information received via email on 14dec2023, it was reported that the nasogastric tube having issues with clogging as they used suction.Stated that to add the adaptor caused the tubing to narrow and this was a huge safety concern.Per additional information received via email on 15dec2023, it was reported that a deidentified snapshot of an x-ray taken at 12:30 morning of a markedly non-functioning nasogastric and confirmed it was the bard tube.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "dimensions not designed correctly".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: "read all instructions prior to use.Do not force nasogastric tube during insertions; damage to the nasal passage and mucosa and bleeding may occur.Measure insertion length carefully- excessive insertion length of tube into the stomach may lead to coiling and/or formation of tube-knot." h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE AND PREVENT® FILTER AND LOPEZ VALVE® WITH ENFIT¿
• Common Device Name: NASOGASTRIC SUMP TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18410268
• Report Number: 1018233-2023-09327
• Device Sequence Number: 19497835
• Product Code: FEG
• UDI-Device Identifier: 00801741113864
• UDI-Public: (01)00801741113864
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K960176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: EN0056160
• Device Lot Number: NGGT2087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown