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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 Name
12ML SYRINGE REGULAR NS
Type of Device
SYRINGE, 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
UDI-Device Identifier10884521010871
UDI-Public10884521010871
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 Other
Type of Report Initial
Report Date 05/28/2020
1 Device was Involved in the Event
1 Patient was 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 No Information
Device Model Number8881112059
Device Catalogue Number8881112059
Device Lot Number19F08463X
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/08/2020
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
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