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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 12ML SYRINGE REGULAR LUER RP SYRINGE, PISTON

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COVIDIEN 12ML SYRINGE REGULAR LUER RP SYRINGE, PISTON Back to Search Results
Model Number 8881512852
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/02/2020
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 reported that they went to transfer blood from the syringe using a blood transfer device and the tip of the syringe broke during the transfer.
 
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Brand Name12ML SYRINGE REGULAR LUER RP
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
815 tek drive
crystal lake IL 60039 9002
Manufacturer (Section G)
COVIDIEN
815 tek drive
crystal lake IL 60039 9002
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key10049468
MDR Text Key190700406
Report Number1424643-2020-00576
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881512852
Device Catalogue Number8881512852
Device Lot Number18K12063X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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