MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD PRECISION GLIDE NEEDLE / INJECTION; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	305129
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Becton, dickinson and company, bd precision glide needle, 21g x 2 (0.8mm x 50mm) injection needle not included in sealed, sterile packaging.Only the cap was in the packaging.

• Brand Name: BD PRECISION GLIDE NEEDLE / INJECTION
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; franklin lakes NJ 07417
• MDR Report Key: 8362957
• Report Number: MW5084230
• Device Sequence Number: 1588051
• Product Code: FMI
• UDI-Device Identifier: 00382903051298
• UDI-Public: (01)00382903051298
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/18/2019

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 Expiration Date: 10/31/2023
• Device Model Number: 305129
• Device Catalogue Number: 305129
• Device Lot Number: 8250832
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR