MAUDE Adverse Event Report: BECTON DICKNSON - FRANKLIN LAKES, NJ / 07417 NEEDLE CLIPPING DEVICE SAFE CLIP; Needle, hypodermic, single lumen

Model Number	328235
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 corrective/preventative action (capa) or situational analysis (sa) is required at this time.Device is not available.
Event or Problem Description
Consumer left voicemail reporting that the bd safe clip needle clipper is not working.Consumer did not provide a contact phone number.No additional information to provide.

• Brand Name: NEEDLE CLIPPING DEVICE SAFE CLIP
• Common Device Name: Needle, hypodermic, single lumen
• Manufacturer (Section D): BECTON DICKNSON - FRANKLIN LAKES, NJ / 07417
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 19112028
• Report Number: 2243072-2024-05010
• Device Sequence Number: 15235843
• Product Code: FMI
• UDI-Device Identifier: 00382903282357
• UDI-Public: 382903282357
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K943683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 328235
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown