MAUDE Adverse Event Report: SOFIC SAS HSI STANDARD NEEDLE PLASTIC HUB 30GA SHORT; HS DENTAL NEEDLE

Lot Number F05985AA

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/20/2017

Event Type  Injury  

Manufacturer Narrative

The needle in question and (b)(4) unused needles from the same reported batch number were received by sofic.The returned needle in question was examined with a microscope.The inspection confirms that the needle broke at the hub, but does not make it possible to know if the needle was bent and to determine the cause of the breakage.All cannulas used by sofic 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 and dynamometer tests carried out by sofic on the returned samples - in order to check the needle breakage rate in extreme conditions of use - did not show any defect.Final comments from manufacturer: therefore, given information available on the circumstances of the incident and the inspection of the affected needle, the possible causes for the reported problem may be the bending of the needle before use, excessive pressure or movement of the needle during injection, the use of a needle size inaccurate to the type of injection, multiple injections with the same needle and/or a sudden movement of the patient during injection.No abnormality was detected on the needles from this batch during analysis and tests.No other complaint was received for this batch out of (b)(4) needles sold.The incident seems to be due to the non-observance of the instructions for use (ifu), especially to the use of a 30g short needle for a nerve block injection, instead of a 27g long needle as recommended on the ifu leaflet.

Event Description

Spontaneous report from (b)(6).Initial information received on 21-jun-2017 from the dentist via (b)(4).The dentist reported that a (b)(6)-year-old female patient, with no specified medical history, had been treated with (b)(4) standard needle plastic hub 30ga short for dental local anesthesia on (b)(6) 2017.The dentist gave an inferior dental (id) block in the lower right back part of the mouth and as she took the needle out, the metal needle got stuck in the patient's mouth.The needle could not seen, so the patient was sent to hospital for an orthopantomogram (opg).The patient had surgery the same day but the hospital was unable to remove the needle as it was encased in muscle.The patient was returning to hospital few days later for another scan and to plan any future treatment.Additional information received on 19-july-2017 with analysis report: no abnormality was detected on the needles from this batch during analysis and tests.No other complaint was received for this batch out of (b)(4) needles sold.No more information was available.Causality assessment on 24-may-2018 on initial information received on 21-jun-2017 and quality investigation results on 19-jul-2017: seriousness: (serious: required intervention to prevent permanent impairment/damage (devices) and other medically important condition).Expectedness: foreign body in gastrointestinal tract: unexpected gb/us; needle issue: unexpected gb/us.Causality: latency - compatible.Recognized association - no.Analysis - during a dental procedure in a (b)(6) year-old female patient, the needle got stuck in the patient's mouth while using the medical device.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.However; quality investigation report didn't show any abnormality or defect on the batch.Therefore the causal relationship between the device and the events was considered as unlikely.Concluded causality who: unlikely.

• Brand Name: HSI STANDARD NEEDLE PLASTIC HUB 30GA SHORT
• Type of Device: HS DENTAL NEEDLE
• Manufacturer (Section D): SOFIC SAS; 3, rue jean-jacques rousseau; aussillon, mazamet cedex 81207 ; FR 81207
• Manufacturer Contact: 3, rue jean-jacques rousseau; aussillon, mazamet cedex 81207
• MDR Report Key: 7573175
• MDR Text Key: 110248711
• Report Number: 3002987375-2018-00007
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 02/28/2022
• Device Lot Number: F05985AA
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2017
• 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): Required Intervention
• Patient Age: 37 YR