| Lot Number F06050AA |
| Device Problem
Break (1069)
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| Patient Problems
Pain (1994); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
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| Event Date 04/05/2018 |
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Event Type
Injury
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Event Description
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Spontaneous report from (b)(6), local reference #(b)(4).Initial information received on (b)(6) 2018 from dentist by email, follow-up 1 information received on (b)(6) 2018 from the dentist by phone and follow-up 2 information received on (b)(6) 2018 from the dentist by email.The dentist reported that a (b)(6) -year-old male patient, with no relevant medical history, had been treated with the medical device septoject, dental needle (batch number : #f06050aa; exp date: feb-2022) for dental local anaesthesia on (b)(6) 2018.The patient already received the same type of product in the past without any complication.The patient was non-smoker and was feeling anxious before dental treatment.No concomitant medication was reported.On (b)(6) 2018, the needle was broken at the junction of the plastic backing and a piece of the needle remained stacked in the mucosa of the patient's cheek.Subsequently, the patient had been admitted to hospital as an emergency.The dentist given the rest of suspected needle and a new sample of needle to the emergency-unit.On (b)(6) 2018, the patient was admitted to the hospital and an unsuccessfully ent-surgery was performed during 3 hours.According to the dentist on (b)(6) 2018, the piece of needle which it was remained in patient's mouth had been successfully removed from the gums.According to the dentist on (b)(6) 2018, the suspected needle was remained in patient's cheek.At the time of the report, the patient's outcome was unknown.No more information available.The company noted discrepancies, first regarding the area of needle was broken, previously, cheek was reported, not the gums and another discrepancy regarding foreign body in mouth, the dentist reported needle did not removed by the specialist, not reported into previously version.Follow-up 1 information provided regarding patient's outcome.Follow-up 2 information provided regarding surgery performed and patient's outcome.Causality assessment on 18-apr-2018 on initial information received on 16-apr-2018, on 17-apr-2018 and on 19-apr-2018: a.Seriousness: serious.B.Listedness/expectedness: foreign body in gastrointestinal tract: unlisted (b)(4), unexpected us/ca/be; needle issue: unlisted (b)(4), unexpected us/ca/be.C.Causality: a) latency - compatible.B) recognized association - no.C) analysis - needle breakage occurred in a (b)(6) -year-old male patient while using the medical device.A piece of the needle was stacked in the patient mouth.The possible causes may be an excessive pressure or movement of the needle during injection, the use of a needle size inappropriate to the type of procedure, possible patients movements during injection due to his anxiety or needle defect.Investigation on the product is pending.Given that no further details are available for the moment, the causal relationship between the device and the events was considered as not assessable.Concluded causality who: not assessable.
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Manufacturer Narrative
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All the canulas used to manufacture this batch of needles were delivered to us with a certificate of compliance with the iso 9626 standard (relative to the stainless steel needle tubing).Stiffness and breakage tests comply with the requirements of the iso 9626 standard.Additional bending tests carried out on reserve samples from the same reported batch - in order to check the needle breakage rate in extreme conditions of use - did not show any abnormality (no cannula breakage).Other tests performed with a dynamometer on the reserve samples on the same reported batch number -- in order to measure the force required to break the cannula -- did not show any defect.The description of the complaint does not specify if the needle was not bent, but indicates that the patient was anxious before injection.The type of injection performed in not mentioned.Considering the description of the incident, it is unknown if all cautions and warnings on the ifu leaflet were observed.Therefore, given the information in our possession on the circumstances of the incident, the possible causes for the reported problem may be bending of the needle prior to injection, excessive pressure or movement of the needle during injection, insertion of the needle to hub, non-observance of single use, the use of a needle size inappropriate to the type of procedure and/or a sudden movement from the patient.Final comments from the manufacturer: no defect related to the needle has been detected during investigation.Considering the description of the incident, a non-observance of the warnings and cautions on the ifu leaaflet by the user cannot be discounted.No other similar complaint was recorded on this needle batch out of (b)(4) needles sold.
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Event Description
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Follow-up information received on 24-may-2018 by email from quality department.Results of quality investigation was received from quality department.No defect related to the needle has been detected during investigation.Considering the description of the incident, non-observance of the warnings an precautions by the user cannot be discounted.No similar complaint has been received on this needle batch out of 113,000 needles sold.Causality assessment re-evaluated on 29-may-2018 on additional information received on 24-may-2018: a.Seriousness: serious.B.Listedness/expectedness: foreign body in gastrointestinal tract: unlisted eu, unexpected us/ca/be; needle issue: unlisted eu, unexpected us/ca/be.C.Causality.A) latency - compatible.B) recognized association - no.C) analysis - needle breakage occurred in a 41-year-old male patient while using the medical device.A piece of the needle was stuck in the patient mouth.The possible causes may be an excessive pressure or movement of the needle during injection, the use of a needle size inappropriate to the type of procedure, possible patients movements during injection due to his anxiety or needle defect.Investigation results showed no defect of the needle.Therefore the causal relationship between the device and the events was considered as unlikely.D) dechallenge - na.E) rechallenge - na.Concluded causality who: unlikely.
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Event Description
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Follow-up information received on 23-oct-2018 from reporting dentist.At the time of this follow-up report, the patient's outcome was not recovered, the needle is still stuck in the patient's mouth.The dentist sent to the company one part of the suspect needle for investigation.Causality assessment re-evaluated on 24-oct-2018 on additional information received on 23-oct-2018: a.Seriousness: serious.B.Listedness/expectedness: foreign body in gastrointestinal tract: unlisted eu, unexpected us/ca/be; needle issue: unlisted eu, unexpected us/ca/be.C.Causality.A) latency - compatible.B) recognized association - no.C) analysis - needle breakage occurred in a 41-year-old male patient while using the medical device.A piece of the needle was stuck.In the patient mouth.The possible causes may be an excessive pressure or movement of the needle during injection, the use of a needle size inappropriate to the type of procedure, possible patients movements during injection due to his anxiety or needle defect.Investigation results showed no defect of the needle.Therefore the causal relationship between the device and the events was considered as unlikely.D) dechallenge - na.E) rechallenge - na.Concluded causality who: unlikely.
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Manufacturer Narrative
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After observation of the sample, the cannula broke level with the base.
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Event Description
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Follow-up 5 information received on 14-mar-2019 from the dentist by email and follow-up 6 information received by email from patient, forwarded by the dentist on 19-mar-2019 were processed together.Follow-up 7 information received on 28-mar-2019 with final investigation report from quality department.According to what the dentist reported on (b)(6) 2019, the patient was worried because he was still suffering from the consequences of the needle breakage in his mouth.Following the unsuccessful operation to remove it on (b)(6) 2018, he experienced trismus (limitation of mouth opening to 1 cm) and had to undergo physiotherapy sessions.He had not fully recovered.According to what the patient reported on (b)(6) 2019, he had a local anaesthesia on (b)(6) 2018 at spix area prior to an unspecified tooth treatment.During the injection, as the patient heard a noise in his mouth, the dentist told him the needle had broken.The next day (on (b)(6) 2018) the 3-hour surgery did not find the needle.According to the patient the surgery had as a consequence trismus (physiotherapy helped him to feel better) and continuous discomfort in mouth (sensation of permanent swelling).His muscles of jaw tired faster.The patient was embarrassed in his daily life when eating, he also bit his cheek and he felt pain.He would like to have more sessions of maxillo-facial physiotherapy to relieve his pain.The patient did not question the skills of the dentist.The patient reported to have not made any movement during the dental procedure as he was anxious during injections.At the time of the report, the patient's outcome was not recovered, the needle was still stuck in the patient's mouth.After observation of the sample, the cannula broke level with the hub.No defect related to the needle has been detected during investigation based.Conclusion of further investigation performed on batch: f06050aa: during the preliminary quality investigation, no product non-conformity was identified, particularly on the resistance of cannulas.According to the latest information received, the occurrence of the incident occurred during anesthesia at the spix spine with a needle septoject xl 30g short 0,30x25mm batch: f06050.The leaflet specifies the needle sizes to be used depending on the practitioner's use.In the context of a troncular injection (spix spine), the minimum length must be 35mm in order to reach the nerve without having to push the needles to the hub.In this case, the needle being 25mm long, the practitioner may have had to push it completely to reach the injection area and resulting in the impossibility of the practitioner to remove the fragment.In addition, this is the first complaint on this batch of needles and cannulas.As a result, the risk is considered minimal.The leaflet mentions various warnings and precautions for use which can prevent the occurrence of this kind of incident.It also specifies in a summary table the different sizes of needles for the different types of injection.Therefore, in the absence of any finding of defect in the needle and in the absence of recurrence recorded on this batch, no corrective actions are necessary.Of note, the needle used septoject xl 30g25 (short needle) was not recommended for the performed procedure nerve block as mentioned in the ifu of the product.Wrong device used was coded by the company.Follow-up 5 information provided regarding patient's outcome, adverse reaction and corrective treatment.Follow-up 6 information provided regarding explanation from patient about the incident.Follow-up 7 information provided regarding final quality investigation results.Causality assessment re-evaluated re-evaluated on (b)(6) 2019 on additional information received on 14-mar-2019 and 19-mar-2019 and re-evaluated on (b)(6) 2019 on additional information received on 28-mar-2019: a.Seriousness: serious.B.Listedness/expectedness: foreign body in gastrointestinal tract: unlisted eu, unexpected us/ca/be.Needle issue: unlisted eu, unexpected us/ca/be.Foreign body in gastrointestinal tract: unexpected us/ca/be.Needle issue: unexpected us/ca/be.Trismus: unexpected us/ca/be.Oral discomfort: unexpected us/ca/be.Chronic cheek biting: unexpected us/ca/be.Oral pain: unexpected us/ca/be.Muscular weakness: unexpected us/ca/be.Wrong device used: unexpected us/ca/be.C.Causality: a) latency: compatible.B) recognized association: no.C) analysis: a needle breakage in the mouth of the patient was reported during the local anesthesia with inferior alveolar nerve block.The needle was broken at the hub.Investigations performed did not reveal any defect.The size of the needle used during this procedure is too short and not appropriate for nerve block anesthesia.In this case, the entire needle may have been introduced into the gum that might have resulted in a breakage.Moreover the short needle does not permit a reorientation of the needle once the anatomical landmarks are identified prior to the effective product injection.No information of others causes/ factors known to cause needle breakage was provided including a bent needle, excessive pressure or movement of the needle during injection, or the use of the needle in spite of an obstacle (bone).No sudden movement of the patient during injection was reported.The needle can not be removed surgically and the patient has not recovered and complaint of sequelae after 11 months.Oral pain, trismus, muscular weakness, oral discomfort and chronic cheek biting appear as sequelae of the stuck needle in the mouth or surgical sequelae to remove the needle.Corrective action: no corrective action was deemed necessary since the product was not found to be defective and the cause of the broken needle is likely related to the use of an inappropriate size of needle for the dental technique being performed by the dentist.The size of the needle to be used for each local anesthesia is clearly mentioned in the instructions for use.Preventive action: no preventive action is necessary as the event is likely related to the use of an inappropriate size of needle for the dental technique being performed by the dentist.Concluded causality who: unlikely for the incident (needle issue and foreign body in gastrointestinal tract); unlikely for the reported events oral pain, trismus, muscular weakness, oral discomfort and chronic cheek biting; not assessable for wrong device used.Follow-up 5 and 6 received in march-2019: the assessment was added for the reported reactions trismus, oral discomfort, chronic cheek biting, oral pain, and muscular weakness.Follow-up 7 information received on 28-mar-2019: assessment not changed.
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