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

Catalog Number	0092100
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was admitted with esphageal varices.Blakemore tube balloon checked.Blakemore tube inserted according to unit policy/procedure.Once placed the device was confirmed by x-ray.The balloon was inflated according to the policy/procedure and bleeding stopped.When traction was applied the device slid out and noted that the balloon was completely deflated.The patient began bleeding a very large amount again and a new blakemore tube had to be placed.No further adverse patient impact.Medical intervention is unknown.
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 patient was admitted with esphageal varicies.Blakemore tube balloon checked.Blakemore tube inserted according to unit policy/procedure.Once placed the device was confirmed by x-ray.The balloon was inflated according to the policy/procedure and bleeding stopped.When traction was applied the device slid out and noted that the balloon was completely deflated.The patient began bleeding a very large amount again and a new blakemore tube had to be placed.No further adverse patient impact.Medical intervention is unknown.Per additional information received via email on 27aug2025, it was reported that patient was in intensive care (icu).
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Received 1 blakemore esophageal-nasogastric tube with label.Verified material number 0092100 and batch number mchv4320.Sample was evaluated and gastric balloon was filled with air and submerged into water where pinhole was present indicated by bubbles leaking out from the hole.This is out of specification.The labeling is found to be adequate to fulfill.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: d, f, h.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 confirmed cause unknown.Received 1 blakemore esophageal-nasogastric tube with label.Verified material number 0092100 and batch number mchv4320.Sample was evaluated and gastric balloon was filled with air and submerged into water where pinhole was present indicated by bubbles leaking out from the hole.This is out of specification per (b)(4) rev 28.The labeling is found to be adequate.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: b, d, h.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 patient was admitted with esphageal varicies.Blakemore tube balloon checked.Blakemore tube inserted according to unit policy/procedure.Once placed the device was confirmed by x-ray.The balloon was inflated according to the policy/procedure and bleeding stopped.When traction was applied the device slid out and noted that the balloon was completely deflated.The patient began bleeding a very large amount again and a new blakemore tube had to be placed.No further adverse patient impact.Medical intervention is unknown.Per additional information received via email on 27aug2025, it was reported that patient was in intensive care (icu).

• Brand Name: BARD® BLAKEMORE ESOPHAGEAL-NASOGASTRIC TUBE
• Common Device Name: BLAKEMORE ESOPHAGEAL-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: 22816289
• Report Number: 1018233-2025-06803
• Device Sequence Number: 9014402
• Product Code: KNT
• UDI-Device Identifier: 00801741076800
• UDI-Public: (01)00801741076800(11)241024(17)260731(10)MCHV4320
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 0092100
• Device Lot Number: MCHV4320
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 01/26/2026; 02/20/2026
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 01/28/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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