MAUDE Adverse Event Report: CARDINAL HEALTH 1180571570 THORA-SEAL II X5; BOTTLE, COLLECTION, VACUUM

Model Number 1180571570

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

The customer reported to tga (therapeutic goods administration) that when providing training to the nursing staff on the setup of the covidien thoraseal ii underwater seal drain unit, the tubing disconnected from the top of the cannister with very little force.This has since happened at 2 further training sessions with different units each time.It should be noted that the instructions include a warning not to lift the unit by the draining tubing.The disconnect happened in general course of setup and demonstration of use; the unit was never lifted.No patient consequences as all incidents occurred during training sessions.Bulletins have been sent to staff and site specific conversations to highlight the risk.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The device history record (dhr) was reviewed showing all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.No sample was returned for evaluation.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).If a sample is returned at a later date, this complaint will be reopened, and the investigation updated to reflect our findings.The complaint could not be confirmed.A corrective and preventative action (capa) will not be initiated because the root cause of the reported event cannot be identified.The associated data will be fed into the risk management quarterly report.This complaint will be used for tracking and trending purposes.

• Brand Name: 1180571570 THORA-SEAL II X5
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18148895
• MDR Text Key: 328286003
• Report Number: 9611018-2023-00633
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

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
• Device Operator: Health Professional
• Device Model Number: 1180571570
• Device Catalogue Number: 1180571570
• Device Lot Number: 21I088FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 01/06/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1