MAUDE Adverse Event Report: HOLLISTER INCORPORATED HOLLISTER; VERTICAL TUBE ATTACHMENT DEVICE - ACCOMODATES 5FR TO 40FR TUBES

Model Number	9782
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dhr review on this sku and lot number was completed and no issues were identified.Unused samples from the same lot were evaluated and met all release criteria.The root cause of the reported clamp separation from the barrier cannot be determined.
Event or Problem Description
It was reported that the clamp portion securing a 16 french tube separated from the barrier portion of a hollister vertical drain tube attachment device.It was reported that the separation occurred sometime between home health care nurse visits which occurred every 3 days.It was further reported that there was no injury or harm to the end user associated with this separation.

• Brand Name: HOLLISTER
• Common Device Name: VERTICAL TUBE ATTACHMENT DEVICE - ACCOMODATES 5FR TO 40FR TUBES
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. IL 60048
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., IL 60048 ; 8479321271
• MDR Report Key: 19069779
• Report Number: 1119193-2024-00009
• Device Sequence Number: 17301036
• Product Code: KNT
• UDI-Device Identifier: 00610075097821
• UDI-Public: 00610075097821
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K932855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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: 9782
• Device Catalogue Number: 9782
• Device Lot Number: 3F18
• 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: 03/19/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown