MAUDE Adverse Event Report: MEDIVATORS, INC. SCOPE BUDDY PLUS TUBING

Model Number	SB110HU1015
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee was filling the scope buddy container with prolystica and in the process, the scope buddy plus tubing "popped off" subsequently causing prolystica to contact the employee's neck.The employee obtained a burn to her neck and chest.No medical treatment was sought or administered.
Additional Manufacturer Narrative
User facility personnel stated that the employee did not put the luer lock on tight.The reported event may be attributed to the employee not properly putting the luer lock on tight subsequently causing the tubing to disconnect.The instructions for use states, "connect luer lock fitting of pump tube to detergent out port.Rotate pump head lever to the left to open pump head.Align flow arrow on pump tube with flow arrow on pump head." the steris account manager in-serviced user facility personnel on the proper use and operating for the scope buddy plus tubing and the importance of ensuring the luer lock is properly connected.The scope buddy plus tubing subject of the reported event was discarded by user facility personnel and is not available for return/evaluation.Without the return of the device, a root cause cannot be determined.User facility personnel were also not able to provide a lot number for the prolystica subject of the reported event.A follow-up report will be submitted should additional information become available.No additional issues have been reported.

• Brand Name: SCOPE BUDDY PLUS TUBING
• Common Device Name: SCOPE BUDDY PLUS TUBING
• Manufacturer (Section D): MEDIVATORS, INC.; 3150 pollok drive; conroe TX 77303
• Manufacturer (Section G): MEDIVATORS, INC.; 3150 pollok dr; conroe TX 77303
• Manufacturer Contact: daniel davy ; 3150 pollok dr; conroe, TX 77303 ; 4403927453
• MDR Report Key: 18339495
• Report Number: 1651395-2023-00066
• Device Sequence Number: 6702936
• Product Code: FEB
• UDI-Device Identifier: 00677964082993
• UDI-Public: 00677964082993
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SB110HU1015
• Device Catalogue Number: SB110HU1015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown