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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
Medical Device Problem Codes Fluid/Blood Leak (1250); Fitting Problem (2183)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional 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 or Problem Description
As per the customer, the syringe will not stay connected to the administration port on the tubing.Additional information received from the customer stated that the plunger seems to be too small for the syringe and no suction with 3 ml syringe when connected to iv lines and leaking was noticed out of the syringe.There was no patient harm reported.
 
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Brand Name
3ML SYRINGE LUER LOCK TIP
Common Device Name
SYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
2010 east international speedw
deland FL 32724
MDR Report Key9468764
Report Number1017768-2019-00758
Device Sequence Number2158990
Product Code FMF
UDI-Device Identifier10884521012301
UDI-Public10884521012301
Combination Product (Y/N)N
Initial Reporter StateMI
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number1180300777
Device Catalogue Number1180300777
Device Lot Number922485
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/02/2019
Initial Report FDA Received Date12/13/2019
Patient Sequence Number1
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