MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD SAFETYGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	305918
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Nurses reported that needles were leaking from the location where the needle meets the pink plastic.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 18535231
• Report Number: 18535231
• Device Sequence Number: 7588002
• Product Code: FMI
• UDI-Device Identifier: 30382903059189
• UDI-Public: (01)30382903059189
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/22/2023
• Report Date (Section F): 09/22/2023

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: Health Professional
• Device Model Number: 305918
• Device Catalogue Number: 305918
• Device Lot Number: 3206801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/22/2023