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

Model Number	0092100
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
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.
Event or Problem Description
It was reported that the blakemore tube was damaged.
Event or Problem Description
It was reported that the blakemore tube was damaged.
Additional Manufacturer Narrative
The reported event was unconfirmed since the problem could not be reproduced.The device did not fail to meet relevant specifications.The product was not used on a patient, therefore it was not used for diagnostic or treatment purposes.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.Blakemore esophageal-nasogastric tube was returned opened with original packaging.The balloon was noted to appear to have portions torn.A photo sample of the blakemore tube was returned as well.Photo showed what appeared to be tears in the tube balloon.Per moncks qe, this is the interface between the glue and balloon cuff.Using a slip tip syringe both balloons were able to be inflated without issue.No leaks were noted.No additional visual defects were noted.Product meets specification which states "the gastric or stomach balloon inflates to specified volume with no problem".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review is not required as the reported event was unconfirmed.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: BLAKEMORE 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12425565
• Report Number: 1018233-2021-05417
• Device Sequence Number: 14354863
• Product Code: KNT
• UDI-Device Identifier: 00801741076800
• UDI-Public: (01)00801741076800
• 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,Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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: 09/30/2023
• Device Model Number: 0092100
• Device Catalogue Number: 0092100
• Device Lot Number: MCEY0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• 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