MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER; NASOGASTRIC TUBE

Catalog Number	0046160
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 nasogastric tube did not have visible numbers.Nurses were required to chart the length of the tube placed and exchange this information in report.They were unable to do this with this product.Staff was unable to visually tell how far the tube has been inserted.Per customer follow up received on 22may2024, the product was still being intermittently stocked on their shelves- all the nurses have been alerted not to use them and use only the ones with the numbers on them so they could document the length each shift and provide it in hand off.Otherwise, there was no way to clearly tell if the tube was in the correct place prior to use.As per the photo sample, the covidien has visible numbers the bard product does not, it only has black marks.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation of the returned two-photo sample noted one unopened (with original packaging), nasogastric tube.Visual inspection of the first photo sample noted the bard nasogastric tube with the black insertion depth marks.The second photo shows the covidien nasogastric tube has visible numbers of marks.This is within " black insertion depth marks must be according to print [2] [6] [7] [9]".No root cause could be found because the reported event was unconfirmed.As the reported event is unconfirmed a labeling review is not required.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Udi format updated with available product information per gudid.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 nasogastric tube did not have visible numbers.Nurses were required to chart the length of the tube placed and exchange this information in report.They were unable to do this with this product.Staff was unable to visually tell how far the tube has been inserted.Per customer follow up received on 22may2024, the product was still being intermittently stocked on their shelves- all the nurses have been alerted not to use them and use only the ones with the numbers on them so they could document the length each shift and provide it in hand off.Otherwise, there was no way to clearly tell if the tube was in the correct place prior to use.As per the photo sample, the covidien has visible numbers the bard product does not, it only has black marks.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX 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: 19407403
• Report Number: 1018233-2024-02999
• Device Sequence Number: 8298993
• Product Code: FEG
• UDI-Device Identifier: 00801741052323
• UDI-Public: (01)00801741052323(11)240113(17)281031(10)NGHY3207
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/08/2024

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: 0046160
• Device Lot Number: NGHY3207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2024
• 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