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

Model Number	305921
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse went to give a vaccination to a newborn.She applied a needle to the prefilled syringe and after she gave the injection to the baby she attempted to deploy the safety device and the safety device broke off.Manufacturer response for safety needle 27 g x 5/8, bd safetyglide (per site reporter).This was done by our supply chain corporate office.I'm not sure what the response was.
Event or Problem Description
Nurse when to give a vaccination to a new born.She applied a needle to the prefilled syringe and after she gave the injection to the baby she attempted to deploy the safety device and the safety device broke off.Manufacturer response for safety needle 27 g x 5/8, bd safetyglide (per site reporter).This was done by our supply chain corporate office.I'm not sure what the response was.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 9841248
• Report Number: 9841248
• Device Sequence Number: 16861984
• Product Code: FMI
• UDI-Device Identifier: 00382903059218
• UDI-Public: 00382903059218
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020
• Report Date (Section F): 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 305921
• Device Catalogue Number: 305921
• Device Lot Number: 9170943
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Date Report Sent to FDA: 01/28/2020