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	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a stray hair found in the peel pouch of specialty tube.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.A labeling review was not performed because labeling could not have prevented the reported failure.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Correction: e.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 there was a stray hair found in the peel pouch of specialty tube.
Additional Manufacturer Narrative
The reported event is confirmed as manufacturing related.Capa 6378919 was initiated to address the reported event.Visual evaluation of the returned one-photo sample noted one unopened with original packaging, nasogastric sump tube.Visual inspection of the one-photo sample noted a strand of hair inside packaging.This does not meet specification per ip7600717, revision 23 which sates "product and package (kit) must be free from visible loose or embedded foreign matter".This specific complaint allegation was part of a broader investigation captured in capa 6378919.The capa investigation conducted a broader review of labeling, complaints, risk management file, raw materials, and manufacturing changes for this product.Based on the results of the investigation, no additional actions can be taken at this time.Corrections: b, d, f, h.Udi format updated with available product information per gudid.H11: sections 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 there was a stray hair found in the peel pouch of specialty tube.As per follow up information received via mail on 28oct2025, it was reported that customer no longer carries the impacted physical product due to the lag time from report to response.Photo sample provided.Lot ngkr1152 was provided.The product was not used on a patient, and the clinical team noticed it prior to using.

• 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 GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22874288
• Report Number: 1018233-2025-06974
• Device Sequence Number: 14875251
• Product Code: FEG
• UDI-Device Identifier: 00801741052323
• UDI-Public: (01)00801741052323(17)300331(10)NGKR1152
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 10/30/2025

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: NGKR1152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/10/2025; 10/30/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/15/2025; 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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