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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 Filling Problem (1233)
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
The customer reported the phlebotomists are complaining that the monoject 6ml syringes are giving a small initial return, but then pulling air while the needle is still inside the vein.It seems the syringe may have a gap at the rubber stopper that is pulling air in when the plunger is pulled back.There was no patient harm.
 
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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 Key11417705
Report Number1915484-2021-01219
Device Sequence Number3976448
Product Code FMF
UDI-Device Identifier10884521013582
UDI-Public10884521013582
Combination Product (Y/N)N
Initial Reporter StateWA
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) 03/04/2021
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 Number1180600777
Device Catalogue Number1180600777
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/26/2021
Initial Report FDA Received Date03/04/2021
Patient Sequence Number1
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