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1.Adverse event description: injection needle with spot (the ink) it started to leak from the back end.So the tech discarded the injection needle and opened another one and a repeated leakage took place.Patient was still under anesthesia.2.Internal investigation of adverse events: according to the customer 's description, we investigate and analyze the structural design, raw materials, manufacturing process, technical standards, test methods, and use methods as follows: 2.1 structural design:this disposable injection needle for endoscope consists of needle, outer tube, inner tube, front handle and infusion handle (luer taper).Analysis: the working principle of disposable injection needle for endoscope is that "the product enters human body through the channel of endoscope, reaches the lesion site, manipulates the handle to extend the needle out of outer tube, pushes the disposable injection needle handle for endoscope to make the needle penetrate into the target tissue for injection".From 2020 to april 2023, a total of about 3.0587 million units of disposable endoscopic injection needles were shipped in this design.A total of feedback was received from the back end of the infusion handle of 5pcs injection needles, with an occurrence probability of 1.63 * 10-6 and a very low occurrence probability, indicating that the structural design was stable and reliable.Therefore, it was determined that the structural design of disposable endoscopic injection needles could meet the clinical requirements, and the feedback of this adverse event was not related to the structural design of disposable endoscopic injection needles 2.2 raw material: this disposable injection needle for endoscope consists of needle, outer tube, inner tube, front handle and infusion handle (luer fitting).Iqc uses 6% luer fitting to detect the infusion handle: the plane of the large end face of the conical fitting cone shall be located between the two limit planes of gauge, and there shall be no obvious swing between gauge and tested fitting (note: ensure that each hole number of the infusion handle used is covered).We inquired about the inspection batches of raw materials corresponding to this batch (m200508323), and the materials, appearance and dimension were qualified for inspection and put into storage.2.3 manufacturing process: from the manufacturing process we investigate all process steps related to cracking performance combined with process risk analysis:a) bonding process of booster tube and infusion handle: when the booster tube and infusion handle are bonded, the operating personnel glue the booster tube, inner tube and infusion handle.The operating personnel will inspect the appearance of infusion handle.Therefore, the defects can be effectively identified due to the poor appearance of injection needle handle at this time.B) process inspection procedure: after the assembly of needle assembly in syringe needle, it is necessary to make leakage test in process inspection: insert the needle into flexible plastic block, the needle shall not be exposed; connect the tail of handle to air valve by luer fitting, place the needle tube and handle part below the water surface, respectively, connect the air pressure of 50kpa (0.05mpa), and keep such state for 15s; observe the handle end and the front end of needle; if any bubble comes out, it is judged as unacceptable (as shown in the following figure).This process is 100% inspection, such as infusion handle leakage, when connected with air valve interface, it can be timely found, so poor infusion handle leakage can be effectively identified.C) fqc process: use 6% luer fitting to make detection on infusion handle; the plane of the large end face of cone hole of inner conical fitting shall be located between the two limit planes of gauge, and there shall be no obvious swing between gauge and tested fitting (note: ensure that each hole number of infusion handle used is covered).D) inner bag packaging process: investigate other processes in the process that may lead to leakage of injection needle, we suspect that after passing the fqc inspection, the finished product of injection needle is transferred to the inner bag packaging process, due to improper turnover material process, resulting in cracking of infusion handle and leakage during injection.Analysis: we investigated the relevant processes that may affect the leakage of injection needle.The process requires that during the production process, the appearance self-inspection is performed after the booster tube and infusion handle are bonded.The assembly of injection needle assembly is completed.The sealing test is completed when entering the process inspection.The operator performs the self-inspection and confirms: visual inspection, the distance is 30-45 cm, there should be no damage, scratch, no overflow on the surface; there are no discoloration spots, black spots, etc., and there is no air leakage in the sealing test; after completing this batch, fill in the dhr.From 2020 to april 2023, the number of disposable endoscopic injection needles shipped in this design is about 305.87 million, and a total of feedback on the leakage of the back end of 5pcs injection needle infusion handle is received, with an occurrence probability of 1.63 * 10-6, and the occurrence probability is very low.In conclusion, the possible causes of leakage of injection needle are: after passing the fqc inspection, the finished products of injection needle are transferred to the inner bag packaging process, and the infusion handle is cracked due to improper operation of the turnover material process, and the liquid leakage occurs during injection.2.4 technical standard:2.4.1 the syringe needle shall be able to operate normally, the force value of control handle shall not exceed 40n, and the needle shall be able to freely enter and exit the external tube.2.4.2 the injection pipeline of injection needle shall be able to inject liquid smoothly and shall have good leakproofness at the same time of injection.2.4.3 the connection between syringe needle and infusion inner tube shall be able to withstand static axial tension of 10n or extension of 50% (whichever comes first) for 10s, without loosening or separation at each joint.2.4.4 the connection between the infusion inner tube of syringe needle and injection handle shall be able to withstand static axial tension of 10n or extension of 50% (whichever is reached first) for 10s, without loosening or separation at each joint.2.4.5 apply an axial static tension of 15n to the joint between the external tube of syringe needle and the handle for 10s, and there shall be no loosening or separation analysis: the adverse event of this needle was described as liquid leakage during injection of the needle found during surgery.The technical standard related to liquid leakage of injection needle is that "the liquid injection pipeline of injection needle shall be able to inject liquid smoothly, and shall have good leakproofness at the same time of liquid injection."performance inspection, meanwhile, we stipulate in the process inspection instruction that"insert the needle into a flexible plastic block, the needle shall not be exposed, connect the tail of handle to the air valve, place the needle tube part and the handle part below the water surface, connect the air pressure of 50kpa (0.05mpa), and keep for 15s, observe the handle end and the front end of needle, if there is bubble coming out, it is judged as unqualified." rom 2020 to april 2023, a total of about 3.0587 million disposable endoscopic injection needles have been shipped in this design.A total of feedback was received from the back end of the infusion handle of the 5pcs injection needle, with an occurrence probability of 1.63 * 10-6.The occurrence probability was very low.In the early verification stage, we also passed a large number of clinical data to prove that the design of the injection needle can objectively meet the product performance requirements, and there is no problem in the setting of technical standards.2.5 test methods: insert the needle into a flexible plastic block; the needle shall not be exposed; connect the tail of handle to air valve, place the needle tube part and the handle part respectively below the water surface, connect an air pressure of 50kpa (0.05mpa), and keep such state for 15s, observe the handle end and the front end of needle; if bubbles appear, it is judged as unacceptable.Analysis: this process is 100% inspection, such as infusion handle cracking leakage, in connection with the air valve interface, can be timely found, so infusion handle leakage cracking can be effectively identified.At the same time, from 2020 to april 2023, a total of about 3.0587 million units of disposable endoscopic injection needles of this design have been shipped, and a total of feedback on the leakage at the back end of the infusion handle of 5pcs injection needles has been received, with an occurrence probability of 1.63 * 10-6 and a very low occurrence probability.Therefore, we confirm that this adverse event is not related to the test method setting.2.6 use methods 2.6.1.The injection needle is used with endoscopes.Before injection connect a syringe full of parenteral solution to the luer lock and inject the solution into the injection needle to remove the air in the perfusion tube and rinse the tube.Note: for proper sealing performance applicable syringe with threaded port is recommended.2.6.2.Put the injection needle into the endoscope's working channel and let it go through the channel slowly into the patient's canal under the surveillance of the endoscope.Make sure the outer tube's distal end is exposed out of the endoscope's working channels distal end.2.6.3.Adjust the endoscope to the optimum position so the needle can accurately reach the injection site.2.6.4.Thoroughly press the handle to limit position so the needle tip extends out of the outer tube, and perform the injection as required.Note: press the handle halfway would cause needle retraction when injecting into the mucosa.2.6.5.When the injection is finished depress the side of the handle to retract the needle tip back into the outer tubeand then pull the injection needle out offend scope's working channel analysis: the adverse event of disposable injection needle for endoscope was described as liquid leakage of injection needle during operation, which affected the operation time.The doctor needed to replace a new injection needle and inject again.It is clarified in the instructions for use that: " before injection connect a syringe full of parenteral solution to the luer lock and inject the solution into the injection needle to remove the air in the perfusion tube and rinse the tube " is clearly described without ambiguity.Therefore, we confirm that this adverse event will not be caused by improper operation of the user due to unclear description of the application method.2.7 storage shipment for the storage and transportation of disposable injection needle for endoscope, we have clear requirements: the product should be stored in a cool drycleanwell-ventilated, non-corrosive gas environment.The sterilization is valid for 3 years.Analysis: the disposable injection needle for endoscope has been proved to be safe and effective within the validity period by perfecting the validity period in the design and development stage.Meanwhile, the disposable injection needle for endoscope has also been verified for transportation to determine that the packaging mode can meet the protection requirements of the product.The more detailed storage and transportation conditions are also described in the instructions for use.Therefore, we determined that the storage and transportation method would not cause this adverse event of the disposable endoscopic injection needle.3.Investigation summary after analyzing and investigating the structural design, raw materials, production process, inspection methods, use methods, storage and transportation of injection needles, we believe that the possible causes of leakage of injection needles are: after passing the fqc inspection, the finished products of injection needles are transferred to the inner bag packaging process, due to improper operation of the turnover material process, the infusion handle is cracked, and leakage occurs during injection.4.Corrective actions.In response to the impact of product bagging factors in the turnover process of the injection needle packaging process in mtn-0001080, mt technology me has trained on the material turnover process to eliminate the recurrence of such abnormalities.Completed date: 2022-10-28(this feedback is the batch number before the introduction of countermeasures, so no repeated training is required).
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