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

Catalog Number 9786

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 327999074
• Report Number: 1480288-2023-00002
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00610075083640
• UDI-Public: 00610075083640
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

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