MAUDE Adverse Event Report: BECTON DICKNSON - FRANKLIN LAKES, NJ / 07417 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

Consumer reported, safeclip is no longer clipping his needles.Stated, he clips 31g needles.Stated, he is sure the device is not full and he may have used it 100 times before it stopped clipping.Lot: 3044001.Catalog: bd safeclip-could not provide product number because the box was discarded date of event: unknown.Sample: yes cl.

• Brand Name: UNKNOWN
• Type of Device: Container, sharps
• Manufacturer (Section D): BECTON DICKNSON - FRANKLIN LAKES, NJ / 07417
• 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: 18915020
• MDR Text Key: 337853659
• Report Number: 2243072-2024-05006
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• 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: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Patient Sequence Number: 1