MAUDE Adverse Event Report: REMINGTON MEDICAL, INC FL-601-97 DISPOSABLE EXTENSION CABLE

Model Number	FL-601-97
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned "opened" cable was tested for fit into a standard female connector.This one cable did not lock into place as designed, confirming the complainant's observation.The eleven "unopened" returned cables were also fit tested.All fit (locked into the female connector) properly as designed.This defective product appears to be a one-time event.Corrective actions are being initiated to prevent a recurrence.
Event or Problem Description
Complainant reported that the icu staff had a problem with the fl-601-97 disposable cable.It could be inserted into the outlet on the epg device, but it would not snap into place and remain firmly connected.Another disposable cable was attached and had no problems.As reported by user facility: "patient had a temporary pacemaker, and dislodge the cables from the pacer box.When the cables were tested, they did not click into a lock position due to a defect.The cables were replaced.A 55 year old male underwent double valve and coronary artery bypass (b)(6) 2023.Two temporary right ventricular pacer wires were in placed, and connected to temporary pacer box after surgery." twelve cables were returned to the manufacturer by the user facility.The returned "opened" cable was tested for fit into a standard female connector.This one cable did not lock into place as designed, confirming the complainant's observation.The eleven "unopened" returned cables were also fit tested.All eleven cables fit (locked into the female connector) properly as designed.The one cable that did not lock into place appears to be a one-time event in which the locking tab on the connector shroud was bent inward slightly from its normal position.Corrective actions are being initiated to prevent a recurrence.

• Brand Name: FL-601-97 DISPOSABLE EXTENSION CABLE
• Common Device Name: DISPOSABLE EXTENSION CABLE
• Manufacturer (Section D): REMINGTON MEDICAL, INC; alpharetta GA
• Manufacturer Contact: 6830 meadowridge court; alpharetta, GA
• MDR Report Key: 16673675
• Report Number: 1056553-2023-00001
• Device Sequence Number: 5434778
• Product Code: DSA
• UDI-Device Identifier: 00813079021285
• UDI-Public: 0100813079021285
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K971968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/31/2023

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: 08/08/2025
• Device Model Number: FL-601-97
• Device Lot Number: 2222043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male