MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD SAFETYGLIDE; SYRINGE, ANTISTICK

Model Number	305945
Health Effect - Clinical Codes	Chest Tightness/Pressure (2463); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Bd safetyglide 1ml syringe 27g x 1/2 (0.4mm x13mm) was used to administer heparin subcutaneously, as ordered.When going to inject patient while using this syringe, primary registered nurse (rn) noted the needle retracted into the syringe somehow upon needle contact with patient.Syringe/needle immediately removed from patient.Needle tip examined, and no signs of anything breaking off.Patient without any injury but had to be poked again with a new syringe/needle in order to receive medication.Ref: 305945, (b)(4), expiration: 2029-01-31, lot number: 4005009b.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 19905446
• Report Number: 19905446
• Device Sequence Number: 7137249
• Product Code: MEG
• UDI-Device Identifier: 00382903059454
• UDI-Public: (01)00382903059454
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/29/2024
• Report Date (Section F): 05/29/2024

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: 305945
• Device Catalogue Number: 305945
• Device Lot Number: 4005009B
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 08/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2024
• 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 Age: 2 MO
• Patient Sex: Female
• Date Report Sent to FDA: 05/29/2024