MAUDE Adverse Event Report: QUALITY IN FLOW LTD. QINFLOW EXTENSION CABLE

Model Number	01
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As requested by fda e-mail on may 25, 2024, the intended purpose of this report is to correct the device information as provided in mdr # 3013429468-2023-00002 to be aligned with the gudid platform.
Event or Problem Description
The extension cable has exposed wires next to the connector.

• Brand Name: QINFLOW EXTENSION CABLE
• Common Device Name: EXTENSION CABLE
• Manufacturer (Section D): QUALITY IN FLOW LTD.; 23 ha-yetsira st.; central; petah tikva, 49512 51; IS 4951251
• Manufacturer (Section G): QUALITY IN FLOW LTD.; 23 ha-yetsira st.; petah tikva, central 49512 51; IS 4951251
• Manufacturer Contact: omer pechter ; 23 ha-yetsira st.; petah tikva, central 49512-51 ; IS 4951251
• MDR Report Key: 19402552
• Report Number: 3013429468-2024-00001
• Device Sequence Number: 20527368
• Product Code: LGZ
• UDI-Device Identifier: 07290016740127
• UDI-Public: 07290016740127
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/28/2024

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 Model Number: 01
• Device Catalogue Number: QIF-CBL00019
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown