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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES DYNJ CUSTOM PACK SURGICAL PACK

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MEDLINE INDUSTRIES DYNJ CUSTOM PACK SURGICAL PACK Back to Search Results
Model Number DYNJ54802B
Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 10/27/2017
Event Type  Malfunction  
Event Description

A hair was found in the major custom pack on an 18 x 18 lap sponge. The entire set up had to be broken down because the hair was discovered after everything was set up. It was discovered prior to patient contact. After sterile field was reset, the procedure was completed as planned. Per site reporter: the medline sales rep was made aware of the situation and will be picking up the lap sponges for investigation.

 
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Brand NameDYNJ CUSTOM PACK
Type of DeviceSURGICAL PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES
three lakes drive
northfield IL 60093
MDR Report Key7070361
MDR Text Key93369164
Report Number7070361
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/17/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/30/2017
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberDYNJ54802B
Device Catalogue NumberDYNJ54802B
Device LOT Number17GD0664
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 The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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