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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SHARPSAFETY; CONTAINER, SHARPS

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COVIDIEN SHARPSAFETY; CONTAINER, SHARPS Back to Search Results
Model Number 8935Y
Device Problem Fracture (1260)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Submit date: 9/12/2018.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.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer states the containers were found cracked when the carton was opened.
 
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Brand Name
SHARPSAFETY
Type of Device
CONTAINER, SHARPS
Manufacturer (Section D)
COVIDIEN
815 tek dr
crystal lake IL 60014 8172
Manufacturer (Section G)
COVIDIEN
815 tek dr
crystal lake IL 60014 8172
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key7869936
MDR Text Key120100730
Report Number1424643-2018-00010
Device Sequence Number1
Product Code MMK
UDI-Device Identifier20884521022420
UDI-Public20884521022420
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/12/2018
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 Health Professional
Device Model Number8935Y
Device Catalogue Number8935Y
Device Lot Number17J03663
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/05/2018
Initial Date FDA Received09/12/2018
Date Device Manufactured11/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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