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

Catalog Number	9786
Medical Device Problem Code	Inadequate or Insufficient Training (1643)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Hypoxia (1918)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint trend analysis conducted for this sku and problem and no adverse trends found.No other complaints found for this lot number.The device history records were reviewed and found to be complete and accurate.The device sample is not available, therefore the root cause of the reported complaint can not be confirmed.The account stated they had not received training on this medical device however the product packaging contains an instruction for use and provides details on how to use the device properly.In addition, hollister is working with the account to address their 9786 hollister feeding tube educational needs.
Event or Problem Description
It was reported that a patient who had a 12 fr feeding tube in place secured by a hollister feeding tube attachment device experienced a tube dislodgement because the clamp did not securely hold the tube in place and the tube was able to slide through the clamp.It was reported that the dislodgement led to aspiration leading to respiratory distress, hypoxia, and tachypnea.It was further reported that crackles were heard in the chest and consolidation in lung was seen on x-ray.It was reported that the patient needed repeated deep suctioning, several days of oxygen therapy, and iv antibiotics.The account reported that the patient recovered from the aspiration event but remains in the hospital for other reasons.The account reported that they switched to the hollister tube attachment device a couple of months ago and had no education or training when this switch was made.

• 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
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville 60048-3781 ; 8476802170
• MDR Report Key: 17255978
• Report Number: 1480288-2023-00001
• Device Sequence Number: 14966931
• Product Code: KNT
• UDI-Device Identifier: 00610075083640
• UDI-Public: 00610075083640
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K893888
• 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): 07/05/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9786
• Device Lot Number: 2H078
• 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: 06/07/2023
• Initial Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 80 KG