MAUDE Adverse Event Report: CASE MEDICAL INC. CASE SOIL INDICATOR ; INDICATOR, PHYSICAL / CHEMICAL STERILIZATION PROCESS

Model Number CSI001

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2019

Event Type  No Answer Provided  

Event Description

Case: soil efficacy.Tests: "soil" is not performing as intended.It comes off too easy and was determined the mfr did not have adequate cure time on the batch of lot# 1274070.Fda safety report id# (b)(4).

• Brand Name: CASE SOIL INDICATOR
• Type of Device: INDICATOR, PHYSICAL / CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): CASE MEDICAL INC. ; south hackensack NJ 07606
• MDR Report Key: 8695878
• MDR Text Key: 148074416
• Report Number: MW5087311
• Device Sequence Number: 1
• Product Code: JOJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSI001
• Device Lot Number: 1274070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1