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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL DELTEC

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NULL DELTEC Back to Search Results
Lot Number 4016329
Device Problems Detachment of Device or Device Component (2907); Fail-Safe Did Not Operate (4046)
Patient Problem No Information (3190)
Event Date 08/01/2020
Event Type  malfunction  
Event Description
Information was received indicating that the safety mechanism was triggered when the deltec gripper plus needle was removed. When placing the needle on a surface, it suddenly jumps apart, the safety mechanism detaches, and the needle is then exposed. There were no adverse events reported.
 
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Brand NameDELTEC
Manufacturer (Section G)
NULL
MDR Report Key11304415
MDR Text Key231109834
Report Number3012307300-2021-01090
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 02/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number4016329
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/11/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/30/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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