MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION MCKESSON PREVENT ® HT SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Model Number N/A

Device Problems Activation Failure (3270); Activation Problem (4042)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/24/2022

Event Type  malfunction  

Event Description

The user facility reported that the mckesson needle involved safety did not lock, and a staff member incurred a needle stick.Additional information was received on 29 jun 2022: the patient was not affected due to the stick.The patient procedure taking place at the time the device was being used was a 25g needle for an im steroid injection.The safety needle was activated on a hard surface visually, however a click was not heard.Health care provider (hcp) had basic first aid and labs drawn at occupational a health clinic.

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation: clinical general manager.The actual sample was not available for our evaluation.The root cause of the complaint could not be identified to be related to our production or process.Retention samples were visually confirmed free from defects that will affect activation of safety sheath and passed evaluation for sheath activation and deactivation.Also, no irregularity was encountered during the simulation of manual sheath activation that may lead to the complaint.We have a series of visual in-process inspections to detect an abnormality on the sheath that may lead to a problem during sheath activation.The molding condition of the components critical to the safety activation of the product is routinely checked to assure that no defects will be encountered that will lead to sheath activation problems and needle sticks.Similarly, the assembly status of the safety needle such as sheath collar fitting and damaged parts that will affect product function is being confirmed.Lot history file revealed no related nonconformity or irregularity that will lead to the complaint.Prior to shipment, qc conducts outgoing visual, sensory, and functional inspections to assure lots are of good quality.Therefore, we advise to follow the instructions for use (ifu) for the proper usage of the sg2 needle indicated on the unit box in which warnings to prevent needle stick, cautions, and precautions are also included.(b)(4).

Manufacturer Narrative

This report is being submitted as follow-up no.1 to correct section h6: medical device problem code.In the initial report the h6: medical device problem code was 4042 however the code should have been 3270.

• Brand Name: MCKESSON PREVENT ® HT SAFETY HYPODERMIC NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna,, ; RP
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 15060467
• MDR Text Key: 304715001
• Report Number: 3003902955-2022-00021
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30612479178855
• UDI-Public: 30612479178855
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 102-N251S
• Device Lot Number: 210317B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IM STEROID INJECTION