MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON DEVICE BOLUS FEEDING TUBE WITH STRAIGHT ADAPTOR, 24F

Model Number	000259
Medical Device Problem Codes	Fluid/Blood Leak (1250); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The device was not returned to the manufacturer for evaluation; however photo was provided.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 000259 feeding tube allegedly fluid leak and deformation due to compressive stress.This information was received from one source.One patient was involved with no reported patient injury.The device was used in a male patient.Age and weight of the patient was not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 000259 feeding tube allegedly had fluid leak and deformation due to compressive stress.This information was received from one source.One patient was involved with no reported patient injury.The device was used in a male patient.Age and weight of the patient was not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for the reported malfunction; therefore, a lot history review was performed.The device was not returned to the manufacturer for evaluation; however photos were provided and reviewed.Therefore, the investigation is inconclusive for the reported leak and deformation issues.A definitive root cause could not be determined based upon available information.The device is labeled for single use.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.

• Brand Name: BARD BUTTON DEVICE BOLUS FEEDING TUBE WITH STRAIGHT ADAPTOR, 24F
• Common Device Name: FEEDING TUBE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10737536
• Report Number: 3006260740-2020-03468
• Device Sequence Number: 16422574
• Product Code: KGC
• UDI-Device Identifier: 00801741080852
• UDI-Public: (01)00801741080852
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: No Information
• Device Model Number: 000259
• Device Catalogue Number: 000259
• Device Lot Number: HUDY1177
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 01/05/2021
• Patient Sequence Number: 1