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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 12ML SYRINGE LUER LOCK (NS) SYRINGE, PISTON

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COVIDIEN 12ML SYRINGE LUER LOCK (NS) SYRINGE, PISTON Back to Search Results
Model Number 8881112083
Device Problem Particulates (1451)
Patient Problem No Patient Involvement (2645)
Event Date 06/19/2020
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.
 
Event Description
Customer reports: particulate and hairs found in 12 ml non sterile syringes. Additional information received states that some of the particulate was free floating.
 
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Brand Name12ML SYRINGE LUER LOCK (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 Key10252735
MDR Text Key198941121
Report Number1424643-2020-00580
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,Followup
Report Date 09/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881112083
Device Catalogue Number8881112083
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 Received06/19/2020
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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