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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 3ML SYRINGE 22G X 1 SYRINGE, PISTON

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COVIDIEN 3ML SYRINGE 22G X 1 SYRINGE, PISTON Back to Search Results
Model Number 1180322100
Device Problems Fluid Leak (1250); Nonstandard Device (1420)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event Description
The customer reported that the human use syringe does not have a tight seal as it squirts out when end user applies pressure. Additional information received stated that the syringes are used primarily for equine but occasionally farm dog/cat, vaccines. The customer despite checking/tightening the luer lock seal, syringes leak (squirt out around luer seal) when they give an injection sometimes after. 4 to. 6 ml of 1ml have gone in the muscle, the rest squirts out with the needle still 1" in the muscle. Sometimes only. 1 to. 2 ml goes in before squirting out.
 
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Brand Name3ML SYRINGE 22G 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
5086183640
MDR Report Key10312042
MDR Text Key199989957
Report Number1017768-2020-00834
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1180322100
Device Catalogue Number1180322100
Device Lot Number513841X
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 Received07/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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