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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SAFETY NEEDLE 25 G X 1" SYRINGE, PISTON

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COVIDIEN SAFETY NEEDLE 25 G X 1" SYRINGE, PISTON Back to Search Results
Model Number 8881850510
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Irritation (1941); No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2019
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. 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 states the luer lock of a 1" needle did not screw on to the syringe causing the vaccine solution to spray on the nurse, mother and baby being vaccinated. According to the customer, no medical attention was needed by anyone involved and there was no harm to anyone involved.
 
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Brand NameSAFETY NEEDLE 25 G X 1"
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
2010 east international speedw
deland FL 32724
Manufacturer (Section G)
COVIDIEN
2010 east international speedw
deland FL 32724
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5084524970
MDR Report Key8420245
MDR Text Key138778815
Report Number1017768-2019-00599
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
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 03/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881850510
Device Catalogue Number8881850510
Device Lot Number827477
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2019
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: 03/14/2019 Patient Sequence Number: 1
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