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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 Code Nonstandard Device (1420)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/25/2019
Type of Reportable Event Malfunction
Additional 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 or Problem Description
The customer reported that the syringe was losing suction and leaking air into the tube.They had to redraw the sample.There was no harm to the patient.
 
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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 Key8846116
Report Number1017768-2019-00663
Device Sequence Number16197273
Product Code FMF
UDI-Device Identifier10884521012301
UDI-Public10884521012301
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
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) 07/31/2019
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 Number910622
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/25/2019
Initial Report FDA Received Date07/31/2019
Patient Sequence Number1
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