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U.S. Department of Health and Human Services

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

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COVIDIEN 12ML SYRINGE REGULAR NS SYRINGE, PISTON Back to Search Results
Model Number 8881112059
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Date 05/08/2020
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 during inspection, they found that the devices had material with flash in the fluid path.
 
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Brand Name12ML SYRINGE REGULAR NS
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 Key10095926
MDR Text Key195256227
Report Number1424643-2020-00577
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeMX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 05/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881112059
Device Catalogue Number8881112059
Device Lot Number19F08463X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2020
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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