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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 6ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON
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COVIDIEN 6ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON Back to Search Results
Model Number 1180600777
Medical Device Problem Code Improper Flow or Infusion (2954)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/02/2019
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 air is entering into the syringe with the blood sample.
 
Additional Manufacturer Narrative
Update: d4 reported lot number is: 923876x.
 
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Brand Name
6ML SYRINGE LUER LOCK TIP
Common Device Name
SYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
MDR Report Key9158634
Report Number1915484-2019-01090
Device Sequence Number11418625
Product Code FMF
UDI-Device Identifier10884521013582
UDI-Public10884521013582
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,health
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/03/2020
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 Number1180600777
Device Catalogue Number1180600777
Device Lot Number923876X
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 10/02/2019
Supplement Date Received by Manufacturer10/02/2019
Initial Report FDA Received Date10/04/2019
Supplement Report FDA Received Date02/03/2020
Patient Sequence Number1
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