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

Model Number	SB-110-HU1007
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and confirmed the device lot was manufactured to specification.The scope buddy plus tubing instructions for use state, "warnings & precautions inspect tubing for leaks and damage to the plastic fittings.Do not use tubing if any damage is noted." users are instructed to wear proper ppe during use of the scope buddy in the user manual.The scope buddy endoscope flushing aid user manual states, "operator safety avoid biological contamination and chemical burns.Always wear appropriate personal protective equipment (ppe) including clothing, gloves, and safety glasses when handling used endoscopes." medivators will evaluate returned product from the customer.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that their scope buddy plus tubing was sliding off during flushing of endoscopes and the sink water is being sprayed onto employees.No report of injury.
Additional Manufacturer Narrative
The customer returned five samples of the tubing to medivators for evaluation.The returned tubing was not labelled, so the lot number of the tubing could not be determined.The packaging for tubing was included with the returned product which was labelled for lot number 532949 and 528534 (lot number subject of this mdr).The tubing is for 24-hour use only.The returned product was tested and three out of the five samples popped off; however, it is unknown how long this tubing had been in use at the user facility.Five samples of current inventory for lot number 536365 at medivators was tested and no issues were noted; the tubing did not pop off.The device history record was reviewed and confirmed the device lot number 528534 was manufactured to specification.The scope buddy plus tubing instructions for use state, "warnings & precautions inspect tubing for leaks and damage to the plastic fittings.Do not use tubing if any damage is noted." users are instructed to wear proper ppe during use of the scope buddy in the user manual.The scope buddy endoscope flushing aid user manual states, "operator safety 2.Avoid biological contamination and chemical burns.Always wear appropriate personal protective equipment (ppe) including clothing, gloves, and safety glasses when handling used endoscopes." 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 ; 9800 59th avenue n; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 13873806
• Report Number: 1651395-2022-00002
• Device Sequence Number: 4666262
• Product Code: FEB
• UDI-Device Identifier: 00677964082924
• UDI-Public: 00677964082924
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K213833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022

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: SB-110-HU1007
• Device Lot Number: 528534
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown