PLEURAFLOW SYSTEM PF-28

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-07 for PLEURAFLOW SYSTEM PF-28 manufactured by Clearflow, Inc..

Event Text Entries

[48030388] The clearance wire loop was found separated from the clearance wire inside the portion of the chest tube outside the chest. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3008782989-2016-00001
• MDR Report Key: 5705134
• Date Received: 2016-06-07
• Date of Report: 2016-06-07
• Date of Event: 2016-05-06
• Date Mfgr Received: 2016-05-12
• Date Added to Maude: 2016-06-07
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: DR. DOV GAL
• Manufacturer Street: 1630 S. SUNKIST ST, SUITE E
• Manufacturer City: ANAHEIM CA 92806
• Manufacturer Country: US
• Manufacturer Postal: 92806
• Manufacturer Phone: 7149165014
• Manufacturer G1: XERIDIEM MEDICAL DEVICES
• Manufacturer Street: 4700 SOUTH OVERLAND DRIVE
• Manufacturer City: TUCSON AZ 85714
• Manufacturer Country: US
• Manufacturer Postal Code: 85714
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: PLEURAFLOW SYSTEM
• Generic Name: PLEURAFLOW SYSTEM
• Product Code: OTK
• Date Received: 2016-06-07
• Model Number: PF-28
• Catalog Number: PF-28
• Lot Number: 928502
• Device Expiration Date: 2018-09-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CLEARFLOW, INC.
• Manufacturer Address: 1630 S. SUNKIST ST. SUITE E ANAHEIM CA 92806 US 92806

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-06-07