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

Model Number	0092100
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
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.
Event or Problem Description
It was reported that three (3) of the blakemore specialty tubes did not inflate prior to being inserted in a patient in the intensive care unit (icu).It was noted that the specialty tubes were not expired.The customer additionally noticed that there was discoloration with the three (3) failed tubes.Each tube was a different lot# and expiration date.Per follow up information received via email on (b)(6) 2023, the clinical education specialist reported that the patient was deceased.The patient was being coded when the endoscopy team arrived to set up the tube, and the code was announced while the endoscopy team was setting up.The team had the blakemore kit set up, and they attempted to test the balloons before use.The balloons from both of the tubes in the kit as well as an additional tube from the icu would not stay inflated.Another tube was obtained from the operating room (or).There was no discoloration noted and the balloons were able to remain inflated.The clinical education specialist stated that the issues encountered with the blakemore tubes did not delay nor impact the outcome.Per clinical follow up information received via email on (b)(6) 2023, the endoscopy associate director reported the 56-year-old female patient was severely ill, and she was admitted to the intensive care unit (icu) due to a gastrointestinal (gi) bleed.The endoscopy team was testing the blakemore kit outside of the patient¿s room while the patient was having a central line inserted and receiving a blood transfusion.The patient coded during this procedure.The endoscopy associate director reported that the patient passed away on (b)(6) 2023 due to the admitting diagnosis, and she confirmed the blakemore tube had no impact on the patient outcome.
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.
Event or Problem Description
It was reported that two (2) of the blakemore specialty tubes did not inflate prior to being inserted in a patient in the intensive care unit (icu).It was noted that the specialty tubes were not expired.The customer additionally noticed that there was discoloration with the two (2) failed tubes.Each tube was a different lot# and expiration date.Per follow up information received via email on 12-june-2023, the clinical education specialist reported that the patient was deceased.The patient was being coded when the endoscopy team arrived to set up the tube, and the code was announced while the endoscopy team was setting up.The team had the blakemore kit set up, and they attempted to test the balloons before use.The balloons in the kit would not stay inflated.Another kit obtained from the icu, but the balloons would not stay inflated.It was also noted that both of these failed devices were discolored.An additional tube was obtained from the operating room (or).There was no discoloration noted and the balloons were able to remain inflated.The clinical education specialist stated that the issues encountered with the blakemore tubes did not delay nor impact the outcome.Per clinical follow up information received via email on 23-june-2023, the endoscopy associate director reported the 56-year-old female patient was severely ill, and she was admitted to the intensive care unit (icu) due to a gastrointestinal (gi) bleed.The endoscopy team was testing the blakemore kits outside of the patient¿s room while the patient was having a central line inserted and receiving a blood transfusion.The patient coded during this procedure.The endoscopy associate director reported that the patient passed away on (b)(6) 2023 due to the admitting diagnosis, and she confirmed the blakemore tube had no impact on the patient outcome.Per clarification information via email on 06jul2023 from the endoscopy associate director, it was stated the events (discoloration and inflation issue) only occurred with 2 devices, which were the samples provided.3 images were originally provided, but the endoscopy associate director stated the third device pictured had normal coloration and inflated correctly.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.No root cause could be found because the reported event was unconfirmed.The device met relevant specifications.Visual evaluation of the returned sample noted one opened (with original packaging), blackmore tube.Visual inspection of the sample noted appeared to have a white powdery substance on the tube with no discoloration observed, inflated the gastric balloon with 200cc of air and clamp off the balloon with the (in-house) hemostat with no issues inflated the esophageal balloon with (5 x 60ml) of air and no inflation issues observed.Also noted that the sample was received with a three-way stop cock inserted in the esophageal funnel and immediately deflated the esophageal balloon.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.As 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 two (2) of the blakemore specialty tubes did not inflate prior to being inserted in a patient in the intensive care unit (icu).It was noted that the specialty tubes were not expired.The customer additionally noticed that there was discoloration with the two (2) failed tubes.Each tube was a different lot# and expiration date.As per follow up information received via email on 12-june-2023, the clinical education specialist reported that the patient was deceased.The patient was being coded when the endoscopy team arrived to set up the tube, and the code was announced while the endoscopy team was setting up.The team had the blakemore kit set up, and they attempted to test the balloons before use.The balloons in the kit would not stay inflated, another kit obtained from the icu, but the balloons would not stay inflated.It was also noted that both of these failed devices were discolored.An additional tube was obtained from the operating room (or).There was no discoloration noted and the balloons were able to remain inflated.The clinical education specialist stated that the issues encountered with the blakemore tubes did not delay nor impact the outcome.Per clinical follow up information received via email on 23-june-2023, the endoscopy associate director reported the 56-year-old female patient was severely ill, and she was admitted to the intensive care unit (icu) due to a gastrointestinal (gi) bleed.The endoscopy team was testing the blakemore kits outside of the patient¿s room while the patient was having a central line inserted and receiving a blood transfusion.The patient coded during this procedure.The endoscopy associate director reported that the patient passed away on 22-apr-2023 due to the admitting diagnosis, and she confirmed the blakemore tube had no impact on the patient outcome.As per clarification information via email on 06jul2023 from the endoscopy associate director, it was stated the events (discoloration and inflation issue) only occurred with 2 devices, which were the samples provided.3 images were originally provided, but the endoscopy associate director stated the third device pictured had normal coloration and inflated correctly.

• 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 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: 17237765
• Report Number: 1018233-2023-04802
• Device Sequence Number: 12531696
• Product Code: KNT
• UDI-Device Identifier: 00801741076831
• UDI-Public: (01)00801741076831
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2023

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: 04/30/2024
• Device Model Number: 0092100
• Device Catalogue Number: 0092300
• Device Lot Number: MCFT0638
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 07/06/2023; 12/14/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 07/31/2023; 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2021
• 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 Age: 56 YR
• Patient Sex: Female