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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 35ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON
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COVIDIEN 35ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON Back to Search Results
Model Number 1183500777
Medical Device Problem Code Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
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
Customer reports: syringes were found with debris and fiber inside, and on the plunger.Syringe also had a blue color inside.
 
Additional Manufacturer Narrative
Initial lot number 1903202464 reported was actually unknown as the customer combined lots.
 
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Brand Name
35ML SYRINGE LUER LOCK TIP
Common Device Name
SYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
MDR Report Key11702291
Report Number1915484-2021-01235
Device Sequence Number3535677
Product Code FMF
UDI-Device Identifier10884521010826
UDI-Public10884521010826
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/29/2021
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 Number1183500777
Device Catalogue Number1183500777
Device Lot Number1917644564
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 04/19/2021
Supplement Date Received by Manufacturer04/19/2021
Initial Report FDA Received Date04/21/2021
Supplement Report FDA Received Date04/29/2021
Patient Sequence Number1
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