MAUDE Adverse Event Report: SOFIC SAS HENRY SCHEIN PREMIUM NEEDLES 30GA SHORT; HSP DENTAL NEEDLE

Catalog Number 02N2301

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/13/2017

Event Type  Injury  

Event Description

Spontaneous report.(b)(4).Initial information received by dealer on 16-jan-2018 and was forwarded to septodont on 17-jan-2018.Reporting dentist has also reported this incident voluntarily to the fda on 16-jan-2018 and received by the agency on 17-jan-2018 (report number as per maude: mw5074653).Additional information received by septodont on 22-jan-2018.A (b)(6) male patient ((b)(6)), with medical history unspecified, had been treated with a suspect device of henry schein premium needle 30ga short (batch # f06309aa, expiration date: 2022-05) on (b)(6) 2017 and the needle broken in the patient's gum tissue.On (b)(6) 2017, the dentist was performing an infiltration nerve block procedure when he noticed that the anesthetic in the needle was leaking from the hub.He reported that he then went to pull out the needle when it broke and became lodged in the patient's gum tissue.He noted that prior to using it, it was not bent.Subsequently, the dentist immediately tried to retrieve the broke off piece with cotton plier forceps and it was unsuccessful.Since he was unsuccessful he then referred the patient to a local oral surgeon that the hygienist drove the patient.Oral surgeon tried to remove it and it was also unsuccessful.The patient was then sent to a hospital [hospital name redacted for privacy] and he was seen on (b)(6) 2018 for removal the piece in patient's mouth, the procedure was unsuccessful.A next specialist consultation was planned to remove it, the reporting dentist advised of the patient to stay overnight.At the time of this incident report, the patient's outcome was not recovered.Causality assessment on 20 feb 2018 on initial information received on 16-jan-2018 and additional information received on 17-jan-2018 and 22-jan-2018: a.Seriousness: serious (required intervention to prevent permanent impairment/damage (devices); hospitalization required) b.Listedness/expectedness: device leakage: unlisted eu, unexpected us; needle issue: unlisted eu, unexpected us; foreign body in gastrointestinal tract: unlisted eu, unexpected us.C.Causality a) latency - compatible b) recognized association -yes c) analysis -this case reported a needle breakage and the broken peace was stuck in patient mouth.This breakage maybe in consequence to: mishandling of the product (e.G.Change of needle direction, important pressure, wrong needle length ) quality defect of the needles based on available information, the causal relationship with the suspect medical device is not assessable.Quality investigation and additional information are requested.D) dechallenge -na e) rechallenge - na concluded causality who: not assessable.

Event Description

Additional information was received on 21-feb-2018 from the quality department.The tests performed allow us to set aside a failure of the cannula.Causality assessment on re-evaluated 28 feb 2018 on initial information received on 16-jan-2018 and additional information received on 17-jan-2018, 22-jan-2018 and 21-feb-2018: a.Seriousness: serious (required intervention to prevent permanent impairment/damage (devices); hospitalization required).B.Listedness/expectedness: device leakage: unlisted eu, unexpected us; needle issue: unlisted eu, unexpected us; foreign body in gastrointestinal tract: unlisted eu, unexpected us.C.Causality.A) latency - compatible.B) recognized association -yes.C) analysis -this case reported a needle breakage and the broken peace was stuck in patient mouth.This breakage maybe in consequence to: mishandling of the product (e.G.Change of needle direction, important pressure, wrong needle length).Quality defect of the needles can be excluded since tests performed allow us to set aside a failure of the cannula.Based on available information, the causal relationship with the suspect medical device is not assessable.Quality investigation and additional information are requested.Concluded causality who: not assessable.

Manufacturer Narrative

All cannulas used by sofic to manufacture this batch of needles were delivered to sofic with a certificate of compliance with the iso 9626 standard (relative to the stainless steel needle tubing).The stiffness and breakage tests performed for this batch of cannulas comply with the requirements of the iso 9626 standard.Additional bending 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 abnormality.Other tests performed by sofic with a dynamometer on the returned samples - in order to measure the force required to break the cannula - did not evidence any defect.Lastly, functional tests on the returned samples aiming at checking that the cannula is not perforated, did not show any liquid leakage.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.Excerpt of cautions: "for single use only: this device is for use in a single patient.Any reuse exposes other patients and the user to critical risks, including infection and trauma since the needle is no longer sterile and is more likely to break." excerpt of warnings: do not bend, break, or otherwise stress needles as serious injuries to you and/or your patient can occur.Do not insert needle to hub during injections, as needles can break and become lodged in patient's tissue, potentially causing serious permanent injury.Do not use short needles (<30 mm) when the expected depth in soft tissue approaches the length of the needle.Avoid extreme pressure and excessive needle movement during injection as this may cause needles to break, which may result in serious injury to you and/or your patient.Be especially vigilant when repositioning a needle in a patient who appears to be apprehensive.The description of the complaint mentions that the needle was not bent and that the incident occurred during a nerve block injection with a 30g short needle.The type of needle used (a thin short needle) instead of a ticker and longer one recommended for this type of injection and the difficulty to retrieve the piece of broken needle let us suppose that the needle was inserted to hub and that it broke at the hub, what may explain the liquid leak at the hub.Therefore, given the information in our possession on the circumstances of the incident, the possible causes for the reported problem may be excessive pressure or movement of the needle during injection, insertion of the needle to hub, non-observance of single use, a sudden movement of the patient during injection and/or the use of a needle size inappropriate to the type of procedure.Final comments from manufacuturer: the tests performed allow us to set aside a failure of the cannula.Considering the description of the incident, the needle breakage seems to be due to the use of a needle size not recommended for this type of procedure - use of a 30g short instead of a 27g long or a 25g long needle recommended on the ifu leaflet, and to the needle insertion to hub.The insertion to hub also engendered the difficulty to retrieve the piece of broken needle from the tissues.The liquid leak may be the consequence of the needle breakage at the hub.

• Brand Name: HENRY SCHEIN PREMIUM NEEDLES 30GA SHORT
• Type of Device: HSP DENTAL NEEDLE
• Manufacturer (Section D): SOFIC SAS; 3, rue jean-jacques rousseau; aussillon, mazamet cedex 81207 ; FR 81207
• MDR Report Key: 7286893
• MDR Text Key: 100606568
• Report Number: 3002987375-2018-00004
• 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
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 02N2301
• Device Lot Number: F06309AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR