MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD 1ML TB SYRINGE; SYRINGE, PISTON

Model Number REF 309626

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/24/2022

Event Type  malfunction  

Event Description

Bd tb syringes do not have safety needle.Needle can come unattached during administration of medication.During administration the needle came off syringe, leaving needle in the patient arm.This caused an increased risk of staff needle stick.Fda safety report id # (b)(4).

• Brand Name: BD 1ML TB SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY
• MDR Report Key: 15348735
• MDR Text Key: 299311338
• Report Number: MW5111856
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/31/2022

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
• Device Operator: Health Professional
• Device Model Number: REF 309626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic