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 05/24/2018

Event Type  Injury  

Event Description

Spontaneous report.(b)(4).Quality complaint was opened by the manufacturer: (b)(4).Initial information received from dealer ((b)(4)) on 25-may-2018 and forwarded to septodont on the same day.Additional information received on 31-may-2018 corrected the suspect batch number from s06893aa to f06893aa.Additional information from reporting dentist was received on 01-jun-2018 with additional details of the reported incident following completion of complaint form.The dentist reported that on (b)(6) 2018, suspect device henry schein premium needle 30ga short (batch # f06893aa, expiration date: 2022-11) was used on a (b)(6) female patient for intraoral procedure, specifically for a intraligamental injection of the lower left molar.The suspect needle reported broke at the tip during the procedure, where the needle separated from the plastic hub and remained in tissue.The broken piece reportedly was extracted successfully from the injection site without complications; it was reported that no harm was done to the patient.The injection site was reported healthy; the dental procedure was eventually performed as intended.Additionally, no discomfort was reported at the time of the use of the suspect device.The patient concerned had not used a similar product as the suspect device in the past.The patient was reported not anxious prior to dental treatment.Reporting dental office also indicated no follow-up treatment was provided to the patient.Causality assessment on 14-jun-2018 on initial information received on 25-may-2018, and additional information received on 31-may-2018 and 01-jun-2018: a.Seriousness: serious (required intervention to prevent permanent impairment/damage (devices)) b.Expectedness: needle issue: unexpected us/ca; foreign body in gastrointestinal tract: unexpected us/ca; no adverse event: expected us/ca.C.Causality a) latency - compatible.B) recognized association - no.C) analysis - during an intraligamental injection of the lower left molar in a patient, the needle broke and got stuck in the tissue.The broken piece was removed successfully by the dentist.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 or needle defect.Request to the dentist for investigation on sample is on-going.Given that no further details are available for the moment, the causal relationship between the device and the events was considered as not assessable.D) dechallenge - na.E) rechallenge - na.Concluded causality who: not assessable.

Manufacturer Narrative

The cannula batch used by sofic to manufacture this batch of needles was delivered to sofic with a certificate of compliance with the iso 9626 standard "stainless steel needle tubing for the manufacture of medical devices - requirements and test methods".The stiffness and breakage tests performed for this batch of cannulas comply with the requirements of the iso 9626 standard.Breakage tests performed by sofic on the 20 returned needles according to iso 9626 did not evidence any abnormality (no trace of breakage).Other tests performed by sofic with a dynamometer on the 20 returned needles - in order to measure the force required to break the cannula - did not evidence 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.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 does not specify if the needle was bent and indicates that the patient was not anxious before injection.The type of injection mentioned is intraligamentary.Therefore considering the description of the incident, we do not know if all cautions and warnings were observed.Therefore, given 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 or non-observance of single use.Final conclusions from manufacturer: no defect related to the needle has been detected during investigation.Considering the description of the incident, a non-observance of warnings and cautions by the user cannot be set aside or validated.

Event Description

Follow-up information received on (b)(6) 2018 from quality department provided information regarding results of investigation.No defect related to the needle has been detected during investigation.Considering the descritpion of the incident, a non-observance of warnings and precautions by the user cannot be set aside or validated.Causality assessment re-evaluated on (b)(6) 2018 on initial information received on (b)(6) 2018, and additional information received on (b)(6) 2018, (b)(6) 2018 and (b)(6) 2018: seriousness: serious (required intervention to prevent permanent impairment/damage (devices).Expectedness: needle issue: unexpected us/ca; foreign body in gastrointestinal tract: unexpected us/ca; no adverse event: expected us/ca.Causality.Latency - compatible.Recognized association - no.Analysis - during an intraligamental injection of the lower left molar in a patient, the needle broke and got stuck in the tissue.The broken piece was removed successfully by the dentist.The possible causes may be an excessive pressure or movement of the needle during injection or possible patients movements during injection.Quality investigation results showed that no issue was detected on the device.Therefore, the causal relationship between the device and the events was considered as unlikely.Dechallenge - na.Rechallenge - na.Concluded causality who: unlikely follow-up (result of investigation): based on quality investigation results the causal relationship was changed from not assessable to unlikely.Concluded causality who: unlikely.

• 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: 7625217
• MDR Text Key: 111883005
• Report Number: 3002987375-2018-00008
• Device Sequence Number: 1
• Product Code: DZM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 02N2301
• Device Lot Number: F06893AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR