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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON
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COVIDIEN 60ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON Back to Search Results
Model Number 1186000777
Medical Device Problem Code Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/29/2020
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 one of the nurses found a plastic part inside the syringe barrel, after just opening it to fill.
 
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Brand Name
60ML SYRINGE LUER LOCK TIP
Common Device Name
SYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
MDR Report Key10331674
Report Number1915484-2020-01178
Device Sequence Number826017
Product Code FMF
UDI-Device Identifier10884521010864
UDI-Public10884521010864
Combination Product (Y/N)N
Initial Reporter StateCA
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) 07/28/2020
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 Number1186000777
Device Catalogue Number1186000777
Device Lot Number006242X
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/07/2020
Initial Report FDA Received Date07/28/2020
Patient Sequence Number1
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