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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SMARTIP MED-PREP CANNULA; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
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COVIDIEN SMARTIP MED-PREP CANNULA; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 8881540111
Medical Device Problem Code Contamination /Decontamination Problem (2895)
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
The customer reported that when the item was opened from the package, the rn noted that there was some sort of contamination to the device.It was discolored with sediment.Additional information received from the customer stated that the contamination with sediment was found inside the syringe barrel.The issue was discovered before use.
 
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Brand Name
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 Key10553629
Report Number1017768-2020-00868
Device Sequence Number11657107
Product Code GEA
UDI-Device Identifier30884521102754
UDI-Public30884521102754
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other,use
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number8881540111
Device Catalogue Number8881540111
Device Lot Number930840
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/16/2020
Initial Report FDA Received Date09/18/2020
Patient Sequence Number1
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