MAUDE Adverse Event Report: BECTON DICKINSON - FRANKLIN LAKES UNKNOWN; Container, sharps

Model Number UNKNOWN

Device Problem Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Information from email copied below.The consumer did not include product information or a phone number where she can be reached.Cl sent: friday, february 9, 2024 11:36 am- embecta awareness date.Sent: 2/6/2024 8:33 am bd awareness date: i purchased a bd safe clip and it will not cut the needles."i have used them for 25 years, but this one will not cut the needle off.May i get a replacement for this one?".

• Brand Name: UNKNOWN
• Type of Device: Container, sharps
• Manufacturer (Section D): BECTON DICKINSON - FRANKLIN LAKES
• Manufacturer (Section G): BECTON DICKINSON AND CO.; 1 becton drive; franklin lakes, NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 18831722
• MDR Text Key: 337464924
• Report Number: 2243072-2024-05005
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1