MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD INTEGRA SYRINGE WITH RETRACTING BD PRECISIONGLIDE NEEDLE 3ML 25G; SYRINGE, PISTON

Model Number 3ML 25G

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/08/2022

Event Type  Injury  

Event Description

While injecting testosterone the metal needle part of the needle broke away from the syringe and embedded directly into my thigh under the skin into the muscle.I was unable to get the metal needle out of my thigh where it currently is.Fda safety report id# (b)(4).

• Brand Name: BD INTEGRA SYRINGE WITH RETRACTING BD PRECISIONGLIDE NEEDLE 3ML 25G
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 14102929
• MDR Text Key: 289255405
• Report Number: MW5108929
• Device Sequence Number: 1
• Product Code: FMF
• 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: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3ML 25G
• Device Lot Number: 1132047
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White