MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HALYARD; TUBE, FEEDING

Model Number	45758
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Dobhoff feeding tubes: since a few months ago, staff reporting issues that after insertion and x-ray confirmation of placement, the guide wire is unable to be removed.Staff also reporting that they are able to flush tube prior to insertion but not after insertion.No change in practice or process.This has occurred at least 10 times, 7 that we area able to confirm with the same lot number.Upon investigation, staff reporting 6-8 times last month that they experienced difficulty, but thought it was their insertion techniques.This has occurred in our hospital and in our long-term acute care hospital (ltach) unit.We have about 4 tubes with packaging that we will be returning to the company.No patients have been directly injured in these incidents: however, they have had to have the tubes removed, replaced, have another x-ray to verify placement.This has caused some delay to initiation of medications and or feedings, but again, no harm or adverse outcome to patients.We reported a similar event about a year ago.Manufacturer response for tube, feeding, halyard (per site reporter).The stock of tubes with the affected lot number have been removed and will be replaced by the company.We will be returning the tubes and packaging to the manufacturer.
Event or Problem Description
Since a few months ago, staff reporting issues that after feeding tube insertion and x-ray confirmation of placement, the guide wire is unable to be removed.Staff also reporting that they are able to flush tube prior to insertion but not after insertion.No change in practice or process.This has occurred at least 10 times, 7 that we are able to confirm with the same lot number.Upon investigation, staff reporting 6-8 times last month that they experienced difficulty, but thought it was their insertion techniques.This has occurred in our hospital and in our long-term acute care hospital (ltach) unit.We have about 4 tubes with packaging that we will be returning to the company.No patients have been directly injured in these incidents: however, they have had to have the tubes removed, replaced, have another x-ray to verify placement.This has caused some delay to initiation of medications and or feedings, but again, no harm or adverse outcome to patients.We reported a similar event about a year ago.Manufacturer response for tube, feeding, halyard (per site reporter).The stock of tubes with the affected lot number have been removed and will be replaced by the company.We will be returning the tubes and packaging to the manufacturer.
Event or Problem Description
Since a few months ago, staff reporting issues that after feeding tube insertion and x-ray confirmation of placement, the guide wire is unable to be removed.Staff also reporting that they are able to flush tube prior to insertion but not after insertion.No change in practice or process.This has occurred at least 10 times, 7 that we are able to confirm with the same lot number.Upon investigation, staff reporting 6-8 times last month that they experienced difficulty, but thought it was their insertion techniques.This has occurred in our hospital and in our long-term acute care hospital (ltach) unit.We have about 4 tubes with packaging that we will be returning to the company.No patients have been directly injured in these incidents: however, they have had to have the tubes removed, replaced, have another x-ray to verify placement.This has caused some delay to initiation of medications and or feedings, but again, no harm or adverse outcome to patients.We reported a similar event about a year ago.Manufacturer response for tube, feeding, halyard (per site reporter).The stock of tubes with the affected lot number have been removed and will be replaced by the company.We will be returning the tubes and packaging to the manufacturer.
Event or Problem Description
Since a few months ago, staff reporting issues that after feeding tube insertion and x-ray confirmation of placement, the guide wire is unable to be removed.Staff also reporting that they are able to flush tube prior to insertion but not after insertion.No change in practice or process.This has occurred at least 10 times, 7 that we are able to confirm with the same lot number.Upon investigation, staff reporting 6-8 times last month that they experienced difficulty, but thought it was their insertion techniques.This has occurred in our hospital and in our long-term acute care hospital (ltach) unit.We have about 4 tubes with packaging that we will be returning to the company.No patients have been directly injured in these incidents: however, they have had to have the tubes removed, replaced, have another x-ray to verify placement.This has caused some delay to initiation of medications and or feedings, but again, no harm or adverse outcome to patients.We reported a similar event about a year ago.The device involved in this report was a halyard product, not a medtronic product as previously described.Manufacturer response for tube, feeding, halyard (per site reporter).The stock of tubes with the affected lot number have been removed and will be replaced by the company.We will be returning the tubes and packaging to the manufacturer.
Event or Problem Description
Since a few months ago, staff reporting issues that after feeding tube insertion and x-ray confirmation of placement, the guide wire is unable to be removed.Staff also reporting that they are able to flush tube prior to insertion but not after insertion.No change in practice or process.This has occurred at least 10 times, 7 that we area able to confirm with the same lot number.Upon investigation, staff reporting 6-8 times last month that they experienced difficulty, but thought it was their insertion techniques.This has occurred in our hospital and in our long-term acute care hospital (ltach) unit.We have about 4 tubes with packaging that we will be returning to the company.No patients have been directly injured in these incidents: however, they have had to have the tubes removed, replaced, have another x-ray to verify placement.This has caused some delay to initiation of medications and or feedings, but again, no harm or adverse outcome to patients.We reported a similar event about a year ago.The device involved in this report was a halyard product, not a medtronic product as previously described.Manufacturer response for tube, feeding, halyard (per site reporter).The stock of tubes with the affected lot number have been removed and will be replaced by the company.We will be returning the tubes and packaging to the manufacturer.

• Brand Name: HALYARD
• Common Device Name: TUBE, FEEDING
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8815329
• Report Number: 8815329
• Device Sequence Number: 3109279
• Product Code: KNT
• UDI-Device Identifier: 10680651457582
• UDI-Public: (01)10680651457582
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/01/2019
• Report Date (Section F): 07/01/2019

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: Health Professional
• Device Model Number: 45758
• Device Catalogue Number: 20-7431AIV2
• Device Lot Number: 0002979520
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 07/23/2019; 07/24/2019; 07/26/2019; 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/01/2019