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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 1CC SAF SYR E100 29X1/2 SYRINGE, PISTON

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COVIDIEN 1CC SAF SYR E100 29X1/2 SYRINGE, PISTON Back to Search Results
Model Number 8881511235
Device Problem Fail-Safe Did Not Operate (4046)
Patient Problem Needle Stick/Puncture (2462)
Event Type  Injury  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it has been discarded; 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.   as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.   if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
The customer reported that there was a needle stick injury with a monoject insulin syringe. The nurse attempted to push the safety shield up over the used needle with their left index finger and the safety shield did not move freely. It was stuck and seemed like it was locked in the original position. A click was not heard and the shield did not extend forward as the safety shield was not able to be activated. The nurse had to go to occupational health to get a tetanus vaccine. Blood was not drawn and there was no further medical intervention. The nurse followed policy and procedure for employee needle sticks at lumc. Source testing was sent on the patient after the needle stick and all results came back negative. At this time no follow up testing or medical intervention is required as all testing results were negative per occupational health.
 
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Brand Name1CC SAF SYR E100 29X1/2
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
Manufacturer (Section G)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key10165125
MDR Text Key195476237
Report Number1915484-2020-01171
Device Sequence Number1
Product Code FMF
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 06/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881511235
Device Catalogue Number8881511235
Device Lot Number004868X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2020
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?
Type of Device Usage

Patient Treatment Data
Date Received: 06/17/2020 Patient Sequence Number: 1
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