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?".

Manufacturer Narrative

Medwatch section c for affected product is attached.Correction to d2, h6 (type of investigation, investigation findings, investigation conclusions).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 capa/sa is required at this time.

• 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,Followup
• Report Date: 05/30/2024
• 2 Devices were Involved in the Event: 1 2

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 Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1