MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY N/A; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	305199
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Obtaining medication pre-procedure, rn attached a pink needle to syringe and inserted syringe into medication and the needle separated from the pink hub which was cracked and the needle remained in the medication.

• Brand Name: N/A
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9985686
• Report Number: 9985686
• Device Sequence Number: 11911557
• Product Code: FMI
• UDI-Device Identifier: 00382903051991
• UDI-Public: (01)00382903051991
• 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): 03/18/2020
• Report Date (Section F): 03/18/2020

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: 305199
• Device Catalogue Number: 305199
• Device Lot Number: 9269108
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/18/2020