MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® NASOGASTRIC SUMP TUBE; NASOGASTRIC TUBE

Catalog Number	0042160
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
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.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.
Event or Problem Description
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.
Event or Problem Description
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.
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".The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.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.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation of the returned sample noted one unopened (without original packaging), used nasogastric sump tube.Visual inspection of the sample noted depth markers present.The sump tube was flushed with 10 ml methylene blue solution (3 drops 1 percentage aqueous methylene blue per 100 ml distilled water) and no leaks noted.No root cause could be found because the reported event was unconfirmed.A device history record review was not required as the investigation was unconfirmed.The reported event is unconfirmed a labeling review is not required.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 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.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE
• 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: 19039951
• Report Number: 1018233-2024-01834
• Device Sequence Number: 15590640
• Product Code: BSS
• UDI-Device Identifier: 00801741052262
• UDI-Public: (01)00801741052262
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2024

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: 0042160
• Device Lot Number: NGHT2135
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 04/05/2024; 06/20/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/08/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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