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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
Device Problems Filling Problem (1233); Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event 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.
 
Manufacturer Narrative
Additional information: h6 health effect- clinical code and impact code added.Medical device problem code, type of investigation, investigation findings, and investigation conclusions added.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.
 
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Brand Name
6ML SYRINGE LUER LOCK TIP
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
MDR Report Key11417487
MDR Text Key239697186
Report Number1915484-2021-01216
Device Sequence Number1
Product Code FMF
UDI-Device Identifier10884521013582
UDI-Public10884521013582
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 03/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number1180600777
Device Catalogue Number1180600777
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/26/2021
Patient Sequence Number1
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