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

Model Number	0092100
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2020
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 during inflation of the gastric balloon, a "dimple" was observed in one side of the balloon.The user initially inflated the balloon with 50-60cc of fluid and then over-inflated with 100cc and touched the balloon in order release the "dimple out".The balloon was then deflated once the "dimple" was released.
Additional Manufacturer Narrative
The reported event was unconfirmed.A blakemore tube was returned with a piece of its original packaging that contained the label showing the product catalog and lot number.Using three slip syringes, the gastric balloon was inflated with 250ccs of air.After each inflation, the blakemore tube was clamped down to prevent air leakage.The balloon was found to be asymmetric.However lack of balloon concentricity and balloon dents are not considered a product defect for blakemore tubes.The investigation indicated that the reported issue was unconfirmed therefore,the device history record was not performed.As the reported event of balloon asymmetry/dents are not considered product defects, a labeling review was not performed.H11:section a through f - the information provided by bd represents all of 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 during inflation of the gastric balloon, a "dimple" was observed in one side of the balloon.The user initially inflated the balloon with 50-60cc of fluid and then over-inflated with 100cc and touched the balloon in order release the "dimple out".The balloon was then deflated once the "dimple" was released.

• 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 GA 30014
• MDR Report Key: 9981775
• Report Number: 1018233-2020-02737
• Device Sequence Number: 3835783
• Product Code: KNT
• UDI-Device Identifier: 00801741076800
• UDI-Public: (01)00801741076800
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

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: 02/28/2022
• Device Model Number: 0092100
• Device Catalogue Number: 0092100
• Device Lot Number: MCDQ2653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1