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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 1920 POP'N COUNT NEEDLE, SUTURING, DISPOSABLE
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COVIDIEN 1920 POP'N COUNT NEEDLE, SUTURING, DISPOSABLE Back to Search Results
Model Number 31142386
Device Problem Material Puncture/Hole (1504)
Patient Problem Needle Stick/Puncture (2462)
Event Type  Injury  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
Customer reports that needle has spliced through the needle counter. The incident has led to a contaminated sharps injury.
 
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Brand Name1920 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
5086183640
MDR Report Key9416764
MDR Text Key169254256
Report Number9612030-2019-02370
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number31142386
Device Catalogue Number31142386
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/05/2019 Patient Sequence Number: 1
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