MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® BLAKEMORE ESOPHAGEAL-NASOGASTRIC TUBE

Catalog Number	0092100
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
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.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 blakemore tube did not inflate completely.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Received 1 blakemore tube.Verified date code hu3027.Visual inspection noted no obvious observations.Sample was evaluated and tear was visibly noted in tubing next to the gastric balloon.Gastric balloon was inflated and submerged in water for leak test.Small bubbles present near tear in tubing at the top of the balloon.This is out of specification that states that any tears or cuts will be rejected (for heads and 4 wing refer to va26a 35 for accept reject status).The labeling is found to be adequate.Dhr was unable to be performed as the lot number was unknown.No additional actions can be taken at this time.Corrections: 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 blakemore tube did not inflate completely.Per customer via email on 24sep2025, it was reported that they did a leak test, placing the tubing in was and inflating.The smaller bulb inflated but did not hold the inflation.The device was not used on the patient.The sample is available.
Event or Problem Description
It was reported that blakemore tube did not inflate completely.Per customer via email on 24sep2025, it was reported that they did a leak test, placing the tubing in was and inflating.The smaller bulb inflated but did not hold the inflation.The device was not used on the patient.The sample is available.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

• Brand Name: BARD® BLAKEMORE ESOPHAGEAL-NASOGASTRIC TUBE
• 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: 23109794
• Report Number: 1018233-2025-08408
• Device Sequence Number: 21345706
• Product Code: KNT
• UDI-Device Identifier: 00801741076800
• UDI-Public: (01)00801741076800(11)230908(17)260531(10)MCHU1076
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/26/2026

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 0092100
• Device Lot Number: MCHU1076
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 01/26/2026; 02/26/2026
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 02/06/2026; 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• 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