MAUDE Adverse Event Report: TERUMO MEDICAL CORP. MCKESSON PREVENT® HT SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Lot Number 201201B

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2023

Event Type  malfunction  

Event Description

Injection given, went to close safety needle and the sheath didn't cover the needle, needle was still exposed--potential to cause an undesired needle stick.

• Brand Name: MCKESSON PREVENT® HT SAFETY HYPODERMIC NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO MEDICAL CORP.; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 16843450
• MDR Text Key: 314306016
• Report Number: 16843450
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 201201B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2023
• Event Location: Other
• Date Report to Manufacturer: 05/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1