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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON
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COVIDIEN 60ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON Back to Search Results
Model Number 1186000777
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Patient Involvement (2645)
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 reports that during preparation, the syringe tip was intact when removed from the wrapper, but when the compounding technician attempted to twist the phaseal luer lock injector onto the syringe, the tip broke off.
 
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Brand Name
60ML SYRINGE LUER LOCK TIP
Common Device Name
SYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
MDR Report Key9936338
Report Number1915484-2020-01148
Device Sequence Number701116
Product Code FMF
UDI-Device Identifier10884521010864
UDI-Public10884521010864
Combination Product (Y/N)N
Initial Reporter StateOH
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) 04/07/2020
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 Number1186000777
Device Catalogue Number1186000777
Device Lot Number935736X
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/12/2020
Initial Report FDA Received Date04/08/2020
Patient Sequence Number1
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