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 Codes	Radiation Exposure, Unintended (3164); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
Line disconnected from hub.The patient had his pluerx inserted on (b)(6) 2021 the lockable line from the insertion kit was connected to an underwater seal drain.Mayrose was speaking to the patient when this happen.The patient just reposition slightly then unintentionally the clear tube/ line disconnected on the lockable line from the white hub connection.She immediately clamped the catheter and disconnected from the lockable line and then capped the plurex catheter.Chest xray was done- fortunately patient was ok , no pneumothorax- he went home.
Event or Problem Description
Line disconnected from hub.The patient had his pluerx inserted on (b)(6) 2021 the lockable line from the insertion kit was connected to an underwater seal drain.(b)(6) was speaking to the patient when this happened.The patient just repositioned slightly then unintentionally the clear tube/ line disconnected on the lockable line from the white hub connection.She immediately clamped the catheter and disconnected from the lockable line and then capped the plurex catheter.Chest xray was done- fortunately patient was ok , no pneumothorax- he went home.
Additional Manufacturer Narrative
(b)(4), follow up emdr for device evaluation: one sample was provided to our quality team for investigation.Upon visual inspection of the sample, it was observed that the access tip was disconnected from drainage line therefore, the reported failure mode was confirmed.Product undergoes inspections throughout manufacturing, as the lot involved in this incident is unknown a device history review could not 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.

• Brand Name: PLEURX LOCKABLE DRAINAGE LINE SET
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• MDR Report Key: 11386447
• Report Number: 9680904-2021-00015
• Device Sequence Number: 14295898
• 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
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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?: 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: 02/04/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 04/09/2021
• 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