MAUDE Adverse Event Report: HOLLISTER INCORPORATED HOLLISTER FEEDING TUBE ATTACHMENT DEVICE; FEEDING TUBE ATTACHMENT DEVICE- ACCOMMODATES 5FR TO 18FR TUBES

Catalog Number	9786
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not saved so sample evaluation cannot be conducted.Dhr review not possible because lot number is not known.Trend analysis conducted and no adverse trends observed.The root cause of the reported lack of adhesion cannot be determined.Regarding the udi information, only the di information is available.Since the lot number was not provided, the pi information is not known.
Event or Problem Description
It was reported that a hollister feeding tube attachment device peeled completely away from the patient's skin dislodging the nasogastric tube it was securing.It was reported that there was no injury but the patient required a reinsertion of the ng tube and additional x-ray.

• Brand Name: HOLLISTER FEEDING TUBE ATTACHMENT DEVICE
• Common Device Name: FEEDING TUBE ATTACHMENT DEVICE- ACCOMMODATES 5FR TO 18FR TUBES
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. IL 60048
• Manufacturer (Section G): SEISA MEDICAL; 9005 montana avenue; el paso
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., IL 60048 ; 8479321271
• MDR Report Key: 21157448
• Report Number: 1480288-2025-00001
• Device Sequence Number: 7631029
• Product Code: KNT
• UDI-Device Identifier: 00610075167760
• UDI-Public: 00610075167760
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/15/2025

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown