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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 3ML SYRINGE LUER LOCK TIP SYRINGE, PISTON

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COVIDIEN 3ML SYRINGE LUER LOCK TIP SYRINGE, PISTON Back to Search Results
Model Number 1180300777
Device Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/03/2020
Event Type  malfunction  
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
The customer reported that after the nurse drew up 2ml of fentanyl from a vial into the syringe at the nurse station, she reapplied the cap. When she arrived at the bedside, her hand felt wet and she observed that the syringe appeared to hold about 25% less medication than it did originally. There was no harm reported.
 
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Brand Name3ML SYRINGE LUER LOCK TIP
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
5086183640
MDR Report Key9810697
MDR Text Key182804632
Report Number1017768-2020-00811
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,user f
Reporter Occupation
Type of Report Initial
Report Date 03/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1180300777
Device Catalogue Number1180300777
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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