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

Model Number FL-601-97

Device Problem Unintended Ejection (1234)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2023

Event Type  malfunction  

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 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
• Type of Device: DISPOSABLE EXTENSION CABLE
• Manufacturer (Section D): REMINGTON MEDICAL, INC; alpharetta GA
• Manufacturer Contact: 6830 meadowridge court; alpharetta, GA
• MDR Report Key: 16673675
• MDR Text Key: 312606118
• Report Number: 1056553-2023-00001
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 00813079021285
• UDI-Public: 0100813079021285
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: FL-601-97
• Device Lot Number: 2222043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male