MAUDE Adverse Event Report: SEPTODONT SEPTOJECT EVOLUTION 30GX1"

Lot Number F03307AA

Device Problems Break (1069); Off-Label Use (1494)

Patient Problems Discomfort (2330); Device Embedded In Tissue or Plaque (3165)

Event Date 08/22/2016

Event Type  Injury  

Manufacturer Narrative

All cannulas used to manufacture this batch of needles were delivered to us with a certificate of compliance with the iso 9626 standard.Stiffness tests comply with the requirements of the iso 9626 standard (relative to the stainless steel needle tubing).Additional bending and dynamometer tests carried out on the returned needles did not show any defect.Warnings and cautions regarding the risks related to product misuse, as well as needle sizes recommended according to the type of injection, are clearly indicated on the box and leaflet.A colored label on the box also indicates the needle size and the type of injection (infiltration).The dentist specified that the needle was not bent.No defect was detected on the needles from this batch.The incident seems to be due to misuse of the product - needle size used inappropriate to the type of procedure, i.E.Use of a 30g25 needle for a mandibular nerve block anesthesia.

Event Description

Spontaneous report.(b)(4).Initial information received by septodont on (b)(6) 2016.Additional information received by septodont on (b)(6) 2016.On (b)(6) 2016, dentist reported to septodont sales representative that suspect device septoject evolution needle 30g short (batch: (b)(4), exp: 2019-11) "broke".Upon contacting the dentist by septodont customer service on 29-aug-2016, additional information was obtained: nature of event: the suspect device broke at the hub; suspect device batch number and expiration date; corrective treatment sought: the patient initially went to an oral surgeon on an unspecified date but the broken needle cannot be removed.The patient subsequent went to see a eye/ear/nose and throat doctor was removed the needle.No patient specifics (gender, age, medical history, aim of dental treatment, etc.) were provided by reporting dentist.Type of injection performed not provided.Date of event: not provided.Date of visit to oral surgeon and to eye/ear/nose and throat doctor: not provided.Additional information received by septodont on 31-aug-2016 and 01-sep-2016: patient demographics: female, age approximately (b)(6), no known allergies, no known concomitant medications, not anxious prior to dental treatment, had been administered with a similar product in the past with no known complications.Event date clarified: (b)(6) 2016.Event resolution date clarified: (b)(6) 2016 (date when needle was removed at hospital); patient was hospitalized; patient's condition improved and adverse reaction disappeared after needle was removed.Indication for dental treatment: restoration; event verbatim updated to: "needle broke during mand.Block anesthesia leaving the needle in patient's cheek"; additional incident details: anesthetic was being administered (local anesthetic not specified) when breakage occurred.Patient was referred to oral surgeon and then to an ear nose & throat surgeon.Injection site was reported healthy; dentist reported that the suspect device involved was not bent prior to injection.Post-op medication was provided at hospital -- according to dentist, he expected antibiotics and pain medication were prescribed to patient post-op.New event term was added as the dentist reported that the patient had discomfort at the time of use of the suspect device.Complaint sample availability: according to dentist, the actual device involved in the incident is no longer available as it was immediately disposed of by staff.Additional adverse event term added on 06-sep-2016: in view that the dentist reported that he had used the suspect device for mandibular block anesthesia, which is not consistent with type of injection "infiltration" as described in the product ifu, adverse event term "intentional device misuse" has been added.Additional information received on 16-sep-2016 from primary manufacturer.Investigation analysis report n°081/16 : no defect was detected on the needles from this batch.The incident may be due to misuse of the needle.Ie needle size for nerve block causality assessment on 02-sep-2016 by (b)(6) of initial information received on (b)(6) 2016 and additional information received on (b)(6) 2016, 31-aug-2016 and 01-sep-2016: seriousness: serious (pt: device breakage - required intervention to prevent permanent impairment/damage).Listedness/expectedness: device breakage: unexpected us/ca; discomfort: expected us/ca.Causality.Latency - not provided.Recognized association - yes.Analysis -this case described an incident in which the needle broke during mandibular block anesthesia leaving the needle in the patient's cheek and require the intervention of oral surgeon to remove the needle.The possible causes of breakage needle may result from a possible involuntary movement of the patient or dentist, a possible movement of needle or an inappropriate size of needle, an excessive pressure changing the resistance of needle during injection, a manufacturing defects.In this case, the fact of a short dental needle (30g short) was used may have contributed to the needle broken.No information about pressure or movement of needle during injection.The patient recovered without sequelae.Dechallenge - yes.Rechallenge - na.Concluded causality who: not assessable.Additional adverse event term added by (b)(6) on 06-sep-2016 after having reviewed the suspect device ifu: pt "intentional device misuse" added.Basis: in view that the dentist reported that he had used the suspect device for mandibular block anesthesia, which is not consistent with type of injection "infiltration" as described in the product ifu, adverse event term "intentional device misuse" has been added as the suspect product was used intentionally and inappropriately used not in accordance with the authorised product information by the reporting dentist.Causality assessment on 16-sep-2016 by (b)(6) on additional information received by primary manufacturer investigation report (analysis report).No defect was detected on the needles from this batch.The incident seems to be due to misuse of the product -needle size used inappropriate to the type of procedure i.E.Use of a 30g25 needle for a mandibular nerve block anaesthesia.Concluded causality who: unlikely.

• Brand Name: SEPTOJECT EVOLUTION 30GX1"
• Type of Device: SEPTOJECT EVOLUTION 30GX1"
• Manufacturer (Section D): SEPTODONT; saint maur des fosses, cedex 94107 ; FR 94107

saint maur des fosses, cedex 94107

• MDR Report Key: 5967707
• MDR Text Key: 55323962
• Report Number: 9610964-2016-00001
• Device Sequence Number: 1
• Product Code: DZM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 11/30/2019
• Device Lot Number: F03307AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR