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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN CONTAINER SHARPS 5QT RED; CONTAINER, SHARPS

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COVIDIEN CONTAINER SHARPS 5QT RED; CONTAINER, SHARPS Back to Search Results
Model Number 8507SA
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2020
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 the sharps container lids are not engaging properly and keep popping back up.It looks like the lids or the container are slightly warped.The lids would snap in fine on one side, but pop back up on the other.There was no harm to patients or staff.
 
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Brand Name
CONTAINER SHARPS 5QT RED
Type of Device
CONTAINER, SHARPS
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 Key11028577
MDR Text Key222072019
Report Number1424643-2020-00588
Device Sequence Number1
Product Code MMK
UDI-Device Identifier10884521023284
UDI-Public10884521023284
Combination Product (y/n)N
Reporter Country CodeUS
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 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number8507SA
Device Catalogue Number8507SA
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 12/09/2020
Initial Date FDA Received12/17/2020
Type of Device Usage N
Patient Sequence Number1
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