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

Model Number 305271

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2024

Event Type  Injury  

Event Description

Got my biweekly testosterone replacement shot from my doctor and the needle point on the syringe either stayed in my leg or fell out after administering the shot.Sent to er (emergency room).Had 2 or 3 x-rays done at urgent care and was sent to the bigger hospital downtown in my city because i was told the needle point was in my leg and he couldn¿t do anything at that location.

• Brand Name: BD INTEGRA SYRINGE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 18544205
• MDR Text Key: 333385003
• Report Number: MW5150543
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 305271
• Device Lot Number: 0113668
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: FAMOTIDINE.; HYDROCORTISONE.; LEVOTHYROXINE. ; LORATADINE.; THISTILE.; VITAMIN C MILK.; VITAMIN D.
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 179 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White