MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD2 SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Model Number N/A

Device Problem Activation Problem (4042)

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

Event Date 12/19/2023

Event Type  malfunction  

Event Description

The hospital pharmacy reported on behalf of a physician that two (2) needles were defective of 2 x 120 mg loading dose injections.After the doctor gave the injections, the safety would not click therefore the needles were exposed when they were discarded in the safety container.The flap did not cover the needle, exposing potential harm to the nurses and physicians.The patient was not injured, and medical/surgical intervention was not needed.There was no ar reported harm or exposure to the health care provider (hcp).The event occurred post-operative.

Manufacturer Narrative

The actual device was not returned; therefore, details of the actual condition of the sample were unable to be determine.Since the lot number is unknown, no evaluation was performed.A total of fifty-seven (57) complaints were received from the previous two fiscal years to the present for the same issue where the cause was not identified as related to our product or production process.Most of the problems are related to usage particularly due to improper activation (not activating on a hard and flat surface in a quick and firm motion).Representative samples of sg2+2525 were subjected to simulation: (i) securely tightened the safety needle to the syringe with a clockwise twisting motion until resistance is felt; (ii) activated the safety sheath on a hard and flat surface (in a quick and firm motion) using a one-handed technique until an audible click is heard; (iii) checked the cannula engagement under the lock (sheath tooth).Results, the needle is fully engaged under the lock (sheath tooth) and no irregularity during activation was encountered that may lead to the complaint.The root cause of the complaint could not be identified.The actual sample was discarded, and no retention sample and records were verified since the lot number is unknown.We have not encountered difficulties or any irregularity during the simulation of the representative samples through manual sheath activation.Moreover, a series of inspections are being performed during in-process and we have an outgoing inspection to check the overall condition of safety needles.Only passed lot samples will be shipped for distribution.We advise following the instructions for use (ifu) indicated in the leaflet for the proper usage of sg2 safety needles in which warnings to prevent needle sticks, cautions, and precautions are also included.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.

• Brand Name: TERUMO SURGUARD2 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, binan ; RP
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 18549229
• MDR Text Key: 333446467
• Report Number: 3003902955-2023-00076
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 34806017507122
• UDI-Public: 34806017507122
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2024
• 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: SG2+2525
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 120 MG LOADING DOSE INJECTIONS