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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE NEEDLE, SUTURING, DISPOSABLE

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MEDLINE INDUSTRIES, INC. MEDLINE NEEDLE, SUTURING, DISPOSABLE Back to Search Results
Catalog Number DYNJNC10A
Device Problem Device Contamination with Body Fluid (2317)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2022
Event Type  malfunction  
Event Description
While making a delivery table, a sterile/packages sharps holder was opened and placed on the delivery table. Upon opening the sharps holder, there was a hair, and skin inside the holder that was supposed to be clean/sterile/right out of the package. Pictures were taken, lot number taken down, all packages with that lot number were removed from the floor and sent to distribution. An email was sent out to staff with the lot number and stated to keep an eye out for any others with that lot number that may have been missed on the floor, not to use them and to send them to distribution if found.
 
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Brand NameMEDLINE
Type of DeviceNEEDLE, SUTURING, DISPOSABLE
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
MDR Report Key13848021
MDR Text Key287619724
Report Number13848021
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/22/2022,02/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberDYNJNC10A
Device Lot Number67021074507
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/22/2022
Date Report to Manufacturer03/22/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

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