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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
Device Problems Break (1069); Fluid Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
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 Description
The customer reports that during preparation, the syringe tip was intact when removed from the wrapper, the compounding technician successfully attached the phaseal luer lock injector onto the syringe, but when the technician attached the phaseal luer lock injector to the phaseal ¿y¿ infusion adapter, the syringe tip broke off. This resulted in chemo spills inside the vertical flow hood.
 
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Brand Name60ML SYRINGE LUER LOCK TIP
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
Manufacturer (Section G)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key9936368
MDR Text Key187520381
Report Number1915484-2020-01149
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 04/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1186000777
Device Catalogue Number1186000777
Device Lot Number935736X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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