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

Model Number N/A

Device Problem Activation Failure (3270)

Patient Problems Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2023

Event Type  malfunction  

Event Description

The user facility reported that the medical assistant (ma) was using the involved mckesson brand prevent ht safety needle ,and when activating the safety, she used her thumb and the sheath moved to the side and incurred a needle stick.The event occurred post-treatment.The patient was not injured, medical or surgical intervention was not required.Additional information was received on 08 march 2023.There was no blood loss.The patient was stable.The injection was completed successfully on the patient.Testing was performed on the nurse who incurred the needle stick.The testing was the usual hiv, hep-b and hep-c testing was performed on the nurse after the needle stick.

Manufacturer Narrative

D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: senior clinical services manager.The actual sample was not available for our evaluation, hence we could not determine the details of its actual condition.Retention samples were visually inspected, and confirmed free from defects that will affect activation of safety sheath such as missing tooth, tooth flash, short shot, flash on the sheath, over or under insertion collar to the hub, sheath-collar fitting, tilted cannula, and damaged parts.Retention samples were further evaluated for sheath activation and deactivation functional test wherein all samples passed.We have received thirty-nine (39) complaints covering fy20 to fy22 march 13, 2023, related to this issue where most of the problems are related to usage particularly due to improper activation of the device.Not activating on the hard and flat surface in a quick and firm motion.Based on the investigation of individual complaints there was no attributable cause noted related to our product and production process.The retention samples were subjected to simulation.The safety needle was securely tightened to the syringe with a clockwise twisting motion until resistance was felt.The safety sheath was activated with a one-handed technique on a hard and flat surface in a quick and firm motion.An audible click was heard indicating successful safety activation.There were no irregularities during or after activation.The sg2 needle did not move and is securely tightened to the syringe.The cannula is fully engaged under the lock (sheath tooth).The safety needle was activated by thumb activation, as stated in the additional information.According to the instructions for use (ifu) of sg2 needles, activation must be performed on a hard and flat surface in a quick and firm motion.Our safety needles meet iso 80369-7 functional and performance requirements.Therefore, the possibility of the safety needle loosening during sheath activation is less likely.The ifu also states that the safety needle must be securely attached to the syringe prior to use to avoid loose fitting.The lot history file revealed no related nonconformity or irregularity that would lead to the complaint.Prior to shipment, qc performs outgoing visual, sensory, and functional inspections to ensure that lots are of good quality.Therefore, we advise following the instructions for use (ifu) for the proper use of the sg2 needle as indicated on the unit box, which also includes needle stick warnings, cautions, and precautions.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.

• 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16666165
• MDR Text Key: 313444557
• Report Number: 3003902955-2023-00013
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• 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: 210903B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2021
• 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
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Race: Asian