MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS RAPICIDE PA; PERACETIC ACID DISINFECTANT

Lot Number 734875

Device Problem Fluid/Blood Leak (1250)

Patient Problems Caustic/Chemical Burns (2549); Chemical Exposure (2570)

Event Date 01/21/2014

Event Type  No Answer Provided  

Event Description

A manager at the (b)(6), opened a case of rapicide and the bottle leaked on her hand causing a burn.

Manufacturer Narrative

It was confirmed there were no formal injury reports, or hospitalizations, related to this incident.This was an isolated incident.No additional information was provided.Product was not returned to manufacturer for evaluation.Cannot determine at this time whether shipping damage contributed to the leak or the bottle seal was not effective.Product labels clearly state to use protective gloves and other appropriate ppe when handling.There are no other related rapicide pa complaints on cap leakage/broken seal.

• Brand Name: MEDIVATORS RAPICIDE PA
• Type of Device: PERACETIC ACID 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: todd hildebrandt ; 14605 28th ave n; minneapolis, MN 55447 ; 7635532487
• MDR Report Key: 3635512
• MDR Text Key: 4178995
• Report Number: 2150060-2014-00005
• Device Sequence Number: 1
• Product Code: FEB
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 734875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1