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

Model Number 9782

Device Problem Material Separation (1562)

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

Event Date 03/01/2024

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 339690059
• Report Number: 1119193-2024-00009
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00610075097821
• UDI-Public: 00610075097821
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K932855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1