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

Catalog Number	0092100
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
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 when trying to inflate the balloon of esophageal tube, the physician notified there was a tear in the crease at the base of the tube.Product was not able to be used to the defect.
Event or Problem Description
It was reported that when trying to inflate the balloon of esophageal tube, the physician notified there was a tear in the crease at the base of the tube.Product was not able to be used to the defect.Per follow-up information received via email on 23feb2024, no medical intervention required.Customer replaced the device with another in stock.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned sample noted one opened (with original packaging), used blakemore esophageal-nasogastric tube.Visual inspection of the sample noted attempted to inflate catheter balloon with 10 ml methylene blue solution (3 drops 1 percentage methylene blue per 100ml distilled water) and leak observed due to tear between two balloons.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be "latex balloon burst or develops holes due to degradation or exposure¿.However, there was insufficient information to confirm this potential root cause.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "warning: it is mandatory, assuming that the balloon has controlled the bleeding, to determine the state of the liver prior to removal of the esophageal balloon.Removal of the balloon too early in an individual with marked prothrombinemia or thrombocytopenia will lead to resumption of bleeding.It is safe to tampon esophageal varices for prolonged periods, months if necessary, in preparation for operation if no traction is applied.Warning: on tube, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Caution: federal u.S.A.Law restricts this device to sale by or on the order of a physician.Storage: store at room temperature away from direct exposure to light, preferably in the original packaging.Sterilization: if sterile use is desired, the tube may be sterilized by ethylene oxide or steam autoclave.Remove plastic plugs prior to sterilization.Typical conditions for ethylene oxide sterilization are 500 mg/l ethylene oxide, 30 to 70 percentage relative humidity, and 120 to 130 degree f.Exposure times will vary depending on the type of equipment used.The equipment manufacturer¿s recommendations should be followed along with the proper use of biological controls.Aeration cycles for the removal of ethylene oxide residues should be carried out according to the equipment manufacturer¿s instructions.Typical conditions for steam sterilization are 20 minutes at 250 degree f or 5 minutes at 270 degree f" corrections: d, e, f, h 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: ESOPHAGEAL-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: 18710544
• Report Number: 1018233-2024-00751
• Device Sequence Number: 8107790
• Product Code: KNT
• UDI-Device Identifier: 00801741076800
• UDI-Public: (01)00801741076800
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 06/11/2024

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 Expiration Date: 07/31/2025
• Device Catalogue Number: 0092100
• Device Lot Number: MCGV4332
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• 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