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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. VASCULAR [PACK] GENERAL SURGERY TRAY

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MEDLINE INDUSTRIES INC. VASCULAR [PACK] GENERAL SURGERY TRAY Back to Search Results
Model Number DYNJ49366
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/29/2021
Event Type  Malfunction  
Event Description

A hole was discovered in the medline vascular pack back table cover during setup resulting in a total tear down of supplies and a case delay. Fda safety report id# (b)(4).

 
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Brand NameVASCULAR [PACK]
Type of DeviceGENERAL SURGERY TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
northfield IL 60093
MDR Report Key11760737
MDR Text Key249000972
Report NumberMW5101128
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/29/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDYNJ49366
Device Catalogue NumberDYNJ49366
Device LOT Number21BRR787
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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