MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® ADULT/PEDIATRIC FEEDING TUBE

Model Number	0036420
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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.The device was not returned.
Event or Problem Description
It was reported that the tube became kinked while in use and caused it to be difficult to remove.
Event or Problem Description
It was reported that the tube became kinked while in use and caused it to be difficult to remove.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "single use.This is a single use device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.".

• Brand Name: BARD® ADULT/PEDIATRIC FEEDING TUBE
• Common Device Name: FEEDING TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8377344
• Report Number: 1018233-2019-01066
• Device Sequence Number: 1486637
• Product Code: FPD
• UDI-Device Identifier: 00801741034428
• UDI-Public: (01)00801741034428
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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: Other
• Device Model Number: 0036420
• Device Catalogue Number: 0036420
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1