MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 NG TUBE W/OUT PREVENT FILTER; NASOGASTRIC TUBE

Model Number	0042160
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be due to "inadequate material selection, design is inadequate".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A labeling review was not performed because labeling could not have prevented the reported failure.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 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 13mar2023, it was reported that the lot for the device was nggs1366.There was no patient impact and the device was disposed of.

• Brand Name: NG TUBE W/OUT PREVENT FILTER
• Common Device Name: NASOGASTRIC 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: 16564749
• Report Number: 1018233-2023-01819
• Device Sequence Number: 5920780
• Product Code: BSS
• UDI-Device Identifier: 00801741052262
• UDI-Public: (01)00801741052262
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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: Lay User/Patient
• Device Model Number: 0042160
• Device Catalogue Number: 0042160
• Device Lot Number: NGGS1366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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