MAUDE Adverse Event Report: CLEARFLOW, INC. PLEURAFLOW SYSTEM WITH FLOWGLIDE

Model Number	PFFG-32
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated and a definite root cause could not be determined.Reported detachment of the chest barb was confirmed.Failure investigation identified the possibility that the guide tube was not fully inserted in the chest barb during assembly.A review of complaint history, drawings, trends, instructions for use, manufacturing instructions, quality control, lot history and visual inspection and dimensional verification of the returned device was conducted during the investigation.Product met all dimensional requirements.No definite cause of failure could be determined.A supplier corrective action was issued to the contract manufacturer.
Event or Problem Description
Device functioned as intended during the first one hour in the operating room.Upon initial use in the icu, the chest barb, a component of the clearance apparatus, separated from the guide tube component of the clearance apparatus.The chest tube was left in the patient's chest and clamped immediately.A new sterile package was opened in the icu and a new clearance apparatus was connected to the chest tube.The device was used with no further problems until its removal at end of normal use.

• Brand Name: PLEURAFLOW SYSTEM WITH FLOWGLIDE
• Common Device Name: PLEURAFLOW SYSTEM WITH FLOWGLIDE
• Manufacturer (Section D): CLEARFLOW, INC.; 1630 s. sunkist street suite e; anaheim CA 92806
• MDR Report Key: 6616895
• Report Number: 3008782989-2017-00005
• Device Sequence Number: 1048574
• Product Code: OTK
• UDI-Device Identifier: 00856449006086
• UDI-Public: 01008564490060861719113010961602
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K163139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/31/2017

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 Expiration Date: 11/30/2019
• Device Model Number: PFFG-32
• Device Catalogue Number: PFFG-32
• Device Lot Number: 961602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2017
• Initial Report FDA Received Date: 06/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 103