MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD INTEGRA RETRACTING PRECISIONGLIDE NEEDLE

Model Number	REF 305311
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to drawing up vaccines, the medical assistant noticed that this needle was not capped in it's original packaging.No injuries noted.

• Brand Name: BD INTEGRA RETRACTING PRECISIONGLIDE NEEDLE
• Common Device Name: RETRACTING PRECISIONGLIDE NEEDLE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; franklin lakes NJ 07417
• MDR Report Key: 7221773
• Report Number: MW5074908
• Device Sequence Number: 1486153
• Product Code: FMF
• UDI-Device Identifier: 00382903053117
• UDI-Public: (01)00382903053117
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/24/2018

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: 10/31/2021
• Device Model Number: REF 305311
• Device Lot Number: 6299679
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1