MAUDE Adverse Event Report: MEDIVATORS INC RAPICIDE PA HIGH LEVEL DISINFECTANT

Model Number	ML02-0117
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The duration of the reported skin redness and irritation was not provided.The technician reported that the cap of the bottle had been loose and that the box containing the bottle of rapicide pa part a had been wet, likely due to chemistry leaking prior to the event.Following the event, the user contacted (b)(6) and was provided the rapicide pa part a sds.No additional medical intervention was sought or required.It is not known if the user was wearing proper ppe at the time of the reported event.The rapicide pa part a sds provides the following warning language and guidance, related to skin exposure and ppe usage: "causes severe skin burns and eye damage.Wash hands thoroughly after handling.Wear protective gloves/protective clothing/eye protection/face protection.If on skin (or hair): rinse skin with water/shower." furthermore, rapicide pa part a is bottled with a vented lid to allow chemical fumigation.The following language is from the rapicide pa label, "store upright in shipping carton.Store in original closed container.Never tamper with vent." it is unknown if the chemistry bottle orientation was changed during transport or storage at the facility.No additional reports of adverse event or harm were received.The bottle subject of the event was not returned for evaluation.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.
Event or Problem Description
A user facility reported that a technician removed a bottle of medivators rapicide pa part a from the box and was splashed by the chemistry on their neck and arm.The technician took a shower to rinse off the chemicals and noted slight redness and irritation of the skin on her arm and neck due to the chemistry exposure.It is unknown if ppe was worn at the time of the event.The technician reported that the chemistry bottle cap had been loose, resulting in the reported event.No additional reports of injury were reported.
Additional Manufacturer Narrative
The duration of the reported skin redness and irritation was not provided.The technician reported that the cap of the bottle had been loose and that the box containing the bottle of rapicide pa part a had been wet, likely due to chemistry leaking prior to the event.It is not known if the user was wearing proper ppe at the time of the reported event.The rapicide pa part a sds provides the following warning language and guidance, related to skin exposure and ppe usage: "causes severe skin burns and eye damage.Wash hands thoroughly after handling.Wear protective gloves/protective clothing/eye protection/face protection.If on skin (or hair): rinse skin with water/shower." furthermore, rapicide pa part a is bottled with a vented lid to allow chemical fumigation.The following language is from the rapicide pa label, "store upright in shipping carton.Store in original closed container.Never tamper with vent." it is unknown if the chemistry bottle orientation was changed during transport or storage at the facility.No additional reports of adverse event or harm were received.The bottle subject of the event was not returned for evaluation.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.

• Brand Name: RAPICIDE PA HIGH LEVEL DISINFECTANT
• Common Device Name: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 9800 59th avenue n; minneapolis, MN 55442 ; 4403927453
• MDR Report Key: 12719715
• Report Number: 2150060-2021-00024
• Device Sequence Number: 3991533
• Product Code: FEB
• UDI-Device Identifier: 00677964090172
• UDI-Public: 00677964090172
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K082988
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: Lay User/Patient
• Device Expiration Date: 03/15/2023
• Device Model Number: ML02-0117
• Device Lot Number: 519996
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown