MAUDE Adverse Event Report: MEDIVATORS RAPICIDE PA HIGH-LEVEL DISINFECTANT, PART B

Model Number ML02-0117

Device Problem Shipping Damage or Problem (1570)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

The user facility reported that a case of rapicide pa high-level disinfectant was delivered in a non-medivators green plastic bag, instead of the medivators cardboard box.While attempting to unpack the shipment of chemistry, an individual at the facility was exposed to fumes and received a burn to their left thumb.The user rinsed their left per the rapicide pa high-level disinfectant sds hazard summary "[rapicide pa high-level disinfectant] causes severe skin burns and eye damage.Harmful if inhaled.May cause respiratory irritation." the sds further requires ppe, including chemically resistant protective gloves, protective clothing, sufficient eye protection and proper a batch history review was performed, which identified no anomalies with the reported lot of product and confirmed that the rapicide pa high-level disinfectant had been shipped in the standard medivators box.It appears that the box was damaged during the shipping process and that the green bag was placed around the chemistry bottles.The event could potentially lead to serious injury if it were to recur.The cause of this situation is shipping/transport damage and subsequent inadequate ppe usage during situations with potential chemical exposure.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.

Event Description

The user facility reported that a shipment of medivators rapicide pa high-level disinfectant was received out of the box.Upon unpacking the shipment, the user reported exposure to the chemistry fumes and a chemical burn received to their left thumb.The user rinsed their left thumb and no further medical intervention was sought.The user reported that they were not wearing gloves at the time that the issue occurred.

Manufacturer Narrative

The user facility reported that a case of rapicide pa high-level disinfectant was delivered in a non-medivators green plastic bag, instead of the medivators cardboard box.While attempting to unpack the shipment of chemistry, an individual at the facility was exposed to fumes and received a burn to their left thumb.The user rinsed their left thumb and no further medical intervention was sought.It was confirmed that the individual was not wearing gloves at the time of the event.No additional injuries or reports of harm were received.Per the rapicide pa high-level disinfectant sds hazard summary "[rapicide pa high-level disinfectant] causes severe skin burns and eye damage.Harmful if inhaled.May cause respiratory irritation." the sds further requires ppe, including chemically resistant protective gloves, protective clothing, sufficient eye protection and proper ventilation.A batch history review was performed, which identified no anomalies with the reported lot of product and confirmed that the rapicide pa high-level disinfectant had been shipped in the standard medivators box.It appears that the box was damaged during the shipping process and that the green bag was placed around the chemistry bottles by the third-party shipping company.The shipping company has been contacted regarding this delivery.The event could potentially lead to serious injury if it were to recur.The cause of this situation is shipping/transport damage and subsequent inadequate ppe usage during situations with potential chemical exposure.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT, PART B
• Type of Device: HIGH-LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• MDR Report Key: 12474862
• MDR Text Key: 271489535
• Report Number: 2150060-2021-00016
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• Combination Product (y/n): N
• PMA/PMN Number: K102996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

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
• Device Operator: No Information
• Device Expiration Date: 01/20/2023
• Device Model Number: ML02-0117
• Device Lot Number: 513109
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1