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

Model Number ML02-0117

Device Problem Device Handling Problem (3265)

Patient Problems Skin Discoloration (2074); Tingling (2171); Chemical Exposure (2570)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

A healthcare facility employee reported rapicide pa high level disinfectant exposure on her fingers while changing the hld containers in their automated endoscope reprocessor.Symptoms reported were white discoloration and tingling.Medivators ra followed up with the exposed personnel and she confirmed she was wearing gloves while handling the hld containers.It was reported that while she was taking off her gloves, she noticed some drops of hld fell on the floor which she wiped up.Shortly after, she began experiencing exposure symptoms on her fingers.She reported washing her hands thoroughly and applied coconut oil to the exposed skin.She reported after 10 minutes, the symptoms went away and she was fine.Rapicide pa instructions for use, labeling, and safety data sheet warn users that the product is harmful if in contact with skin and instructs users to wear protective gloves.This complaint will continue being monitored in medivators complaint handling system.

Event Description

A healthcare facility employee reported rapicide pa high level disinfectant exposure on her fingers while changing the hld containers in their automated endoscope reprocessor.Symptoms reported were white discoloration and tingling.

• Brand Name: RAPICIDE PA
• Type of Device: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 7667059
• MDR Text Key: 113334458
• Report Number: 2150060-2018-00047
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00067796403619
• UDI-Public: 0067796403619
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ML02-0117
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other