MAUDE Adverse Event Report: HOLLISTER INCORPORATED HOLLISTER FEEDING TUBE ATTACHMENT DEVICE

Catalog Number	9786
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not saved so sample evaluation cannot be conducted.Dhr reviewed and records found to be complete and accurate.Trend analysis conducted and no adverse trends observed.The root cause of the reported lack of adhesion cannot be determined.Based on the information the hospital reported, they are not preparing the patient's skin in accordance with the 9786 ifu.The hospital reported that they use cavilon wipes to clean the area.Cavilon wipes are a no sting barrier film.Hollister's ifu states to clean with residue-free soap.Product usage retraining was provided by hollister to the account.
Event or Problem Description
It was reported that the tape on the hollister feeding tube attachment device did not stay secured to the patient's nose and the nasogastric tube was able to dislodge.It was further reported that the tape adhered to the nose for less than 24 hours.The account went on to report that this impacted the patient's length of stay as they required another procedure to insert a tube.They also reported that the tube is a nasojejunal tube for feeding and required insertion under sedation and until reinserted, they were not meeting their nutritional requirements.

• Brand Name: HOLLISTER FEEDING TUBE ATTACHMENT DEVICE
• Common Device Name: HOLLISTER FEEDING TUBE ATTACHMENT DEVICE
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. IL 60048
• Manufacturer (Section G): SEISA MEDICAL; 9005 montana avenue; el paso TX 79925
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., IL 60048 ; 8479321271
• MDR Report Key: 18129514
• Report Number: 1480288-2023-00002
• Device Sequence Number: 20490080
• Product Code: KNT
• UDI-Device Identifier: 00610075083640
• UDI-Public: 00610075083640
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9786
• Device Lot Number: 2L048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown