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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HDQ PARSIPPANY UNKNOWN; CONTAINER, SHARPS

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HDQ PARSIPPANY UNKNOWN; CONTAINER, SHARPS Back to Search Results
Model Number UNKNOWN
Device Problem Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
H3 other text : product not available.
 
Event Description
Consumer reported lid is missing from sharps container prior to use.Discarded box.Product information is not available stated, she purchased a 1.4qt.Sharps container.Date of event: unknown sample: no cl.
 
Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
 
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Brand Name
UNKNOWN
Type of Device
CONTAINER, SHARPS
Manufacturer (Section D)
HDQ PARSIPPANY
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes, NJ 07417
Manufacturer Contact
avital merl
300 kimball dr.
parsippany, NJ 07054
MDR Report Key18639157
MDR Text Key334512294
Report Number2243072-2024-05002
Device Sequence Number1
Product Code MMK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/02/2024
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 Lay User/Patient
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/08/2024
Initial Date FDA Received02/05/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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