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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 1910 POP'N COUNT NEEDLE, SUTURING, DISPOSABLE

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COVIDIEN 1910 POP'N COUNT NEEDLE, SUTURING, DISPOSABLE Back to Search Results
Model Number 31142394
Device Problem Material Puncture/Hole (1504)
Patient Problem Needle Stick/Puncture (2462)
Event Date 12/13/2018
Event Type  Injury  
Event Description
The customer reported that the prescott va was trialing a product that resulted in a nurse being stuck with a used needle. Additional information received from the customer states: the nurse who was trialing the product placed the used needle into the needle counter. It was a fine needle, not a large bore needle. She closed the lid, without resistance when closing, and locked the side with the slide lock. When she picked up the needle counter to place it into the sharps container, she was stuck with the used needle, which had punctured through the bottom of the plastic needle counter.
 
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Brand Name1910 POP'N COUNT
Type of DeviceNEEDLE, SUTURING, DISPOSABLE
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX 22500
Manufacturer (Section G)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX 22500
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5084524970
MDR Report Key8217855
MDR Text Key132099245
Report Number9612030-2019-02071
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number31142394
Device Catalogue Number31142394
Device Lot Number1814107564
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/04/2019 Patient Sequence Number: 1
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