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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; DRAPE, SURGICAL
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MEDLINE INDUSTRIES, INC. MEDLINE; DRAPE, SURGICAL Back to Search Results
Model Number MDT2168204
Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/10/2017
Event Type  malfunction  
Event Description
A small bug was found in opened disposable blue towel on sterile field.The sterile set up was broken down before anything was used.The bug was photographed and the towel/packaging was saved.No harm came to the patient.The sterile field was reset and the procedure was completed as planned.Per site reporter: the medline rep was made aware and will alert their quality department.The towel will be handed over to the medline rep for return.
 
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Brand Name
MEDLINE
Type of Device
DRAPE, SURGICAL
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
MDR Report Key7070381
MDR Text Key93369305
Report Number7070381
Device Sequence Number1
Product Code KKX
UDI-Device Identifier20080196834058
UDI-Public(01)20080196834058
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2017
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberMDT2168204
Device Catalogue NumberMDT2168204
Device Lot Number84317060148
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/17/2017
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer11/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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