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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: E K INDUSTRIES, INC. FORMALIN JAR; FORMALIN, NEUTRAL BUFFERED
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E K INDUSTRIES, INC. FORMALIN JAR; FORMALIN, NEUTRAL BUFFERED Back to Search Results
Model Number EKI4499100X60
Device Problems Crack (1135); Product Quality Problem (1506)
Patient Problem Insufficient Information (4580)
Event Date 01/11/2023
Event Type  malfunction  
Event Description
Lid cracking with minimal twisting.We have had another incidence today with same lot number.We order them through our medline distributor.Company name on bottle; eki (1-800-283-4244).Manufacturer response for formalin jar, formalin jar (per site reporter) requested manufacturer item# from site, asked [redacted name] to retrieve, pulled tracker report for formalin jars.Cc'd [redacted name] and asked if he would be the van to evaluate new products due to all of the issues with these (bugs in jars, cracked lids, quality issues).[redacted date]- sample retrieved.[redacted date]- emailed [redacted name], medline.[redacted date]- email sent to eki rep.; eki rep response received and will take action.
 
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Brand Name
FORMALIN JAR
Type of Device
FORMALIN, NEUTRAL BUFFERED
Manufacturer (Section D)
E K INDUSTRIES, INC.
1403 herkimer st
joliet IL 60432
MDR Report Key16333785
MDR Text Key309145684
Report Number16333785
Device Sequence Number1
Product Code IFP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/30/2023
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? Yes
Device Model NumberEKI4499100X60
Device Lot Number2215441
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/30/2023
Event Location Hospital
Date Report to Manufacturer02/09/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/09/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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