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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 3ML SMARTIP MED-PREP CANNULA; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
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COVIDIEN 3ML SMARTIP MED-PREP CANNULA; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 8881540133
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/11/2019
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
The customer reported that the monoject syringe/needle combo had a back spray while a nurse was withdrawing medication.It appears there was a hole in the blunt tip, allowing it to spray 90 degrees.She experienced it twice.
 
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Brand Name
3ML SMARTIP MED-PREP CANNULA
Common Device Name
CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
COVIDIEN
2010 east international speedw
deland FL 32724
MDR Report Key9142178
Report Number1017768-2019-00692
Device Sequence Number19585147
Product Code GEA
UDI-Device Identifier10884521082946
UDI-Public10884521082946
Combination Product (Y/N)N
Initial Reporter StateWI
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) 10/01/2019
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 Number8881540133
Device Catalogue Number8881540133
Device Lot Number912300
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/11/2019
Initial Report FDA Received Date10/01/2019
Patient Sequence Number1
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