MAUDE Adverse Event Report: SEPTODONT SEPTOJECT XL

Model Number 27G LONG

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/27/2018

Event Type  Injury  

Event Description

Spontaneous report, local reference # (b)(4).Quality complaint reference :# (b)(4).Initial information received on (b)(6) 2018 via dealer (b)(6); forward to septodont on the same day.On an unspecified date, a patient (gender, age, medical history, intention for dental treatment not specified), was receiving a block with suspect device septoject xl 27g long (batch # f07152aa; expiration date: feb-2023).The suspect septoject xl reported broke at the hub, ultimately leaving the needle inside the patient.The reporting dental office is currently working on getting the needle removed.Additional information is currently being sought by the dealer at the time of this initial report.Causality assessment on 24-aug-2018 on initial information received on (b)(6) 2018: seriousness: serious (reported incident considered other medically important condition and required intervention to prevent permanent impairment/damage (devices)).Expectedness: foreign body in gastrointestinal tract: unexpected us/ca device breakage: expected us/ca.Causality: latency, recognized association, analysis.This case reported that the suspect device septoject xl broke at the hub, leaving the needle inside the patient mouth.No information is provided regarding the method used for the block anesthesia (site, upper or lower maxillary, etc.).The needle breakage might be a consequence of a product mishandling (important pressure, movement, inadequate size of needle), the other reason might be a product defect investigation on this batch are ongoing.The presence of broken part of the needle inside the patient's mouth is a consequence of this breakage.This case is deemed unassessable due to lack of information.De-challenge -na; rechallenge - na.Concluded causality who: unassessable.

Event Description

Follow-up information was received on 10-aug-2018 and 31-aug-2018 from dealer.Initial information and follow-up information received are integrated in the below case narrative.On (b)(6) 2018, a male patient aged 27 years, was receiving a upper block with suspect device septoject xl 27g long (batch # f07152aa; expiration date: feb-2023) for scaling and root planing.The suspect septoject xl reported broke at the hub, ultimately leaving the needle inside the patient's mouth.The reporting dental office has always used "these types of needles with no issues".On (b)(6) 2018, the patient was scheduled to return to the dental office in attempt to remove the needle.Outcome of this followup visit was not specified.On (b)(6) 2018, the patient visited an oral surgeon; the device fragment was removed successfully.As of (b)(6) 2018, the patient is doing well.Quality investigation is ongoing; dealer has not yet received samples from reporting dental office.Follow-up information received on 10-aug-2018: patient demographics, event date, medical history, scheduled dental visit date, reporter information and patient's reaction outcome status were updated by dealer; follow-up information received on 31-aug-2018: patient outcome, additional details on the follow-up treatments received by patient and sample status were provided by dealer.Causality assessment re-evaluated on 05-sep-2018 with additional information received on 10-aug-2018 and 31-aug-2018: no change in the initial causality assessment performed on 24-aug-2018.Concluded causality who: unassessable.

Event Description

Follow-up information was received on 22-nov-2018 from quality department with investigation results.The reporting dental office has always used "these types of needles with no issues".As of 22-nov-2018, dealer has not yet received samples from reporting dental office.Additional information received regarding results of quality investigation: this is the first complaint received for the needle cannula batch concerned and for the suspect device batch.No abnormality that could have an impact on product quality was recorded during the manufacturing of the suspect device batch.No defect related to the needle was observed during testing of reserve samples of the suspect in the absence of the needle in question and in the absence of defect detected during our tests, the root cause of the reported incident could not be determined.Considering investigation results and the description of the incident, the potential cause of misuse by the practitioner cannot be set aside or validated: bending of the needle, pressure during injection exerting high force onto the cannula, sudden movement during injection.Moreover it might be that needle insertion to hub may had led the need for the needle fragment be retrieved surgically.It is recommended that the practitioner observe the device instruction for use again on the proper use of the device.Follow-up information received on 22-nov-2018: quality investigation results received.Causality assessment re-evaluated on 20-dec-2018 on additional information received on 22-nov-2018: c.Causality c.Analysis.The needle breakage might be a consequence of a product mishandling (important pressure, movement, inadequate size of needle), the other reason might be a product defect investigation but the quality investigation has excluded it.Concluded causality who: unassessable.

• Brand Name: SEPTOJECT XL
• Type of Device: SEPTOJECT XL
• Manufacturer (Section D): SEPTODONT; 58, rue du pont de creteil; saint maur, cedex val-de-marne, 94107 ; FR 94107
• MDR Report Key: 7838545
• MDR Text Key: 119026496
• Report Number: 0001721729-2018-00008
• Device Sequence Number: 1
• Product Code: DZM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2018,12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 27G LONG
• Device Catalogue Number: 01N1550
• Device Lot Number: F07152AA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/07/2018
• Distributor Facility Aware Date: 08/10/2018
• Event Location: Other
• Date Report to Manufacturer: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 27 YR