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

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.

• Brand Name: SHARPS CONTAINER (BD)
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 12446269
• MDR Text Key: 270989001
• Report Number: MW5103780
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): Y
• Number of Events Reported: 1
• 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

• Date FDA Received: 09/08/2021
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR