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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 16G X 1 1/2 A (ALUM HUB) RP; NEEDLE, HYPODERMIC, SINGLE LUMEN
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COVIDIEN 16G X 1 1/2 A (ALUM HUB) RP; NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Model Number 8881200037
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/03/2019
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.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 16 gauge needle coring the vial membrane.Additional information received from the customer stated that the issue was noticed before use.There was no patient harm reported.
 
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Brand Name
16G X 1 1/2 A (ALUM HUB) RP
Common Device Name
NEEDLE, HYPODERMIC, SINGLE LUMEN
Manufacturer (Section D)
COVIDIEN
2010 east international speedw
deland FL 32724
MDR Report Key9467086
Report Number1017768-2019-00756
Device Sequence Number2934832
Product Code FMI
UDI-Device Identifier30884521007530
UDI-Public30884521007530
Combination Product (Y/N)N
Initial Reporter StateMI
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) 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 Number8881200037
Device Catalogue Number8881200037
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/04/2019
Initial Report FDA Received Date12/13/2019
Patient Sequence Number1
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