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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 12ML SYRINGE LUER LOCK TIP SYRINGE, PISTON

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COVIDIEN 12ML SYRINGE LUER LOCK TIP SYRINGE, PISTON Back to Search Results
Model Number 1181200777
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/13/2021
Event Type  malfunction  
Manufacturer Narrative
The incident sample has been received and is being forwarded to the manufacturing plant for evaluation. When the investigation is complete 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 they have found contamination in and on the syringes. It appears to be black or green mold like and is found in the stock on a variety of floors. Additional information received stated the contamination is both inside and outside the syringe in the fluid path.
 
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Brand Name12ML SYRINGE LUER LOCK TIP
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 Key11870132
MDR Text Key252167873
Report Number1424643-2021-00602
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 07/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1181200777
Device Catalogue Number1181200777
Device Lot Number20M02563X
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 Received05/13/2021
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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