• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SHARPS CONTAINER (BD); CONTAINER, SHARPS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON SHARPS CONTAINER (BD); CONTAINER, SHARPS Back to Search Results
Device Problem Defective Component (2292)
Patient Problem Insufficient Information (4580)
Event Date 05/01/2021
Event Type  malfunction  
Event Description
Indication: age-related osteoporosis without current pathological fracture.Spontaneous: per pt, calling about a defected sharps container.No adverse drug event reported; unknown if device/container is available for return; unknown lot/expiration.No further information known.Sharps container used to dispose of tymlos needles - tymlos dose 80 mcg sq daily.Reported to (b)(6) by pt/caregiver.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SHARPS CONTAINER (BD)
Type of Device
CONTAINER, SHARPS
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key12446269
MDR Text Key270989001
Report NumberMW5103780
Device Sequence Number1
Product Code MMK
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/04/2021
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/08/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age75 YR
-
-