MAUDE Adverse Event Report: PLEURX LOCKABLE DRAINAGE LINE SET; APPARATUS, SUCTION, PATIENT CARE

Model Number	50-7245
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
Tube came away from lockable tip.A patient on the hematology ward had a drainage line attached to the ipc, which connected to the chest drain.I was advised that the tubing disconnected from the adapter.The nurses reconnected it and taped the section between the tubing and adapter to ensure it didn't disconnect again.They attempted to access another drainage line but had no success, as the situation occurred during night duty.I have sent you the picture where the line disconnected.
Additional Manufacturer Narrative
(b)(4) follow up emdr: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.Product undergoes inspections throughout manufacturing, as the lot involved in this incident is unknown, a complaint history review cannot be performed.Based on the available information, we are not able to identify a root cause at this time.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
Tube came away from lockable tip.A patient on the hematology ward had a drainage line attached to the ipc, which connected to the chest drain.I was advised that the tubing disconnected from the adapter.The nurses reconnected it and taped the section between the tubing and adapter to ensure it didn¿t disconnect again.They attempted to access another drainage line but had no success, as the situation occurred during night duty.I have sent you the picture where the line disconnected.
Event or Problem Description
Tube came away from lockable tip.A patient on the hematology ward had a drainage line attached to the ipc, which connected to the chest drain.I was advised that the tubing disconnected from the adapter.The nurses reconnected it and taped the section between the tubing and adapter to ensure it didn't disconnect again.They attempted to access another drainage line but had no success, as the situation occurred during night duty.I have sent you the picture where the line disconnected.
Additional Manufacturer Narrative
(b)(4) follow up emdr for device evaluation/correction one photo sample was provided to our quality team for investigation.Through visual inspection, the drainage line is noted to have tape near the connection of the access tip and drainage line, however, it is not possible to properly identify if there is a disconnection of those components.Product undergoes inspections throughout manufacturing, as the lot involved in this incident is unknown, a complaint history review cannot be performed.Based on the available information, we are not able to identify a root cause at this time.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text: see manufacturer narrative.

• Brand Name: PLEURX LOCKABLE DRAINAGE LINE SET
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• MDR Report Key: 11556258
• Report Number: 9680904-2021-00027
• Device Sequence Number: 14465435
• Product Code: DWM
• UDI-Device Identifier: 10885403174872
• UDI-Public: (01)10885403174872
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2021

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: 50-7245
• Device Catalogue Number: 50-7245
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 04/09/2021; 08/20/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/09/2021; 08/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other