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

Lot Number 0266458

Device Problems Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 01/31/2021

Event Type  malfunction  

Event Description

Syringe failed during use; while injecting 1.0ml of testosterone the syringe failed, plunger made an unusual pop sound and drug went into the negative space behind plunger seal, little to no drug was injected into my body.Fda safety report id # (b)(4).

• Brand Name: BD INTEGRA SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 11273091
• MDR Text Key: 230585411
• Report Number: MW5099187
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• 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: 01/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 0266458
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 73