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

Model Number 0092100

Device Problems Inflation Problem (1310); Dent in Material (2526)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event 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.

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 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
• Type of Device: BLAKEMORE TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9981775
• MDR Text Key: 188647971
• Report Number: 1018233-2020-02737
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741076800
• UDI-Public: (01)00801741076800
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/21/2020
• Supplement Dates Manufacturer Received: 06/22/2020
• Supplement Dates FDA Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1