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

Catalog Number 02N2301

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 03/14/2018

Event Type  Injury  

Event Description

Spontaneous report, (b)(4).Initial information was received on 22-mar-2018 from dealer henry schein ((b)(4)) who received the information on 21-mar-2018.Additional information was received directly by septodont via email on 29-mar-2018.This case involved a (b)(6) male patient ((b)(6)), with a previous medical history of smokeless tobacco and a cracked tooth filling on tooth #19.On (b)(6) 2018, the patient received an intra-alveloar nerve injection for dental crown treatment on tooth #19 with suspect device henry schein premium 30ga short needle (batch # f06553aa, expiration date: 2022-08).The suspect device broke off at the hub, it came off completely and became lodged in the jaw of the patient on the left side of the mouth in the back by the molar.It and was not visible clinically and the broken needle could not be retrieved intraorally by the reporting dentist.Approximately 60 minutes following injection with the suspect device, the patient started experiencing "dull ache" on the lower left side prior to dismissal from the dental office.No swelling was noted by the reporting dentist prior to patient dismissal.The patient was given a prescription of antibiotics and pain medication (amoxicillin and ibuprofen) as post-operative medications (dosage, posology and duration not provided).The patient was sent for computerized tomography imaging.The patient's current outcome is unknown.The reporting dentist is not sure if the patient had to be hospitalized as a result of this incident.No sequelae has been noted by the reporting dentist.The patient was not anxious prior dental treatment.He did not take medication and had no known allergies.The reporting dentist has indicated that the patient has not returned any calls made by the dentist.Causality assessment on 10-apr-2018 on initial information received on 21-mar-2018 and additional information received on 29-mar-2018: a.Seriousness: serious (device breakage: required intervention to prevent permanent impairment/damage (devices); foreign body in gastrointestinal tract: important medical condition).B.Listedness/expectedness: device breakage: listed eu; expected us/ca.Foreign body in gastrointestinal tract: unlisted eu; unexpected us/ca.Oral pain: unlisted eu; unexpected us/ca.C.Causality a) latency - compatible b) recognized association - no c) analysis - the possible causes for the reported event may be the bending of the needle before use, excessive pressure or movement of the needle during injection, a sudden movement of the patient during injection and/or the use of a needle size inappropriate to the type of procedure.Pending a quality analysis report, the causal relationship between the device and the incident was considered as not assessable.Oral pain may be a consequence of the dental procedure or be related to a trauma following the device breakage and needle lodged in the jaw of the patient.However no information was reported about patient outcome after dental dismissal.Therefore the causal relationship between the device and oral pain was assessed as unlikely, given the particular context of device breakage.D) dechallenge - na e) rechallenge - na concluded causality who: not assessable for device breakage and foreign body in gastrointestinal tract, unlikely for oral pain.

Event Description

Follow-up information received on 26-apr-2018 by email from quality department provided information regarding results of investigation.Conclusions of the tests performed allow the quality department to set aside a failure of the cannula.Considering the investigation, the needle breakage seemed to be due to the non-observance of the ifu, especially 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.Other potential causes cannot be set aside.No similar complaint has been received on this needle batch out of (b)(4) needles sold.The incident was notified to fda by sofic (initial report submission date: 20-apr-2018).The batch initially mentioned for the complaint was f06439aa.Additional information received mention batch no.F06553aa.Therefore the batch affected by the complaint is f06553aa.For the analysis report, 2 boxes from batch f06439aa have been received.No samples from batch f06553aa have been received.Causality assessment re-evaluated on 14-may-2018 on additional information received on 26-apr-2018: a.Seriousness: serious (device breakage: required intervention to prevent permanent impairment/damage (devices); foreign body in gastrointestinal tract: important medical condition).B.Listedness/expectedness: device breakage: listed eu; expected us/(b)(6).Foreign body in gastrointestinal tract: unlisted eu; unexpected us/(b)(6).Oral pain: unlisted eu; unexpected us/(b)(6).C.Causality a) latency - compatible b) recognized association - no.C) analysis - the possible causes for the reported event may be the bending of the needle before use, excessive pressure or movement of the needle during injection, a sudden movement of the patient during injection, insertion of the needle to the hub, non-observance of single use and/or the use of a needle size inappropriate to the type of procedure.Quality analysis report showed no abnormality in needle breakage rate and force required to break the cannula but did not concern the batch affected by the complaint.The causal relationship between the device and the incident was considered as not assessable, but other mentioned causes seemed more probable.Oral pain may be a consequence of the dental procedure or be related to a trauma following the device breakage and needle lodged in the jaw of the patient.However no information was reported about patient outcome after dental dismissal.Therefore the causal relationship between the device and oral pain was assessed as unlikely, given the particular context of device breakage.D) dechallenge - na.E) rechallenge - na.Concluded causality who: not assessable for device breakage and foreign body in gastrointestinal tract, unlikely for oral pain.

Manufacturer Narrative

The cannula batch used to manufacture this batch of needles was 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 reserve 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 reserve samples - 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 ifu as summarized below: for periapical injections: extrashort: (0.3 x 10 mm / 30ga x 3/8"); short (0.3 x 25 mm / 30 ga x 1"); short (0.4 x 25 mm / 27 ga x 1"); short (0.5 x 25 mm / 25 ga x 1").For nerve block injections: long (0.4 x 35 mm / 27 ga x 1 3/8"); long (0.4 x 35 mm / 25 ga x 1 3/8").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." "it is the responsibility of the practitioner, expert in his field, to select the needle reference (length/diameter) taking into account the risks described in instruction." 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, but indicates that the patient was not anxious.The type of injection mentioned is a nerve block one.Therefore we can see that the type of needle used is not recommended on the instructions for this type of injection - use of a 30g short needle whereas the ifu leaflet recommends 27g long or 25g long needles for nerve block injections.Given the 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, excessive pressure or movement of the needle during injection, insertion of the needle to hub, non-observance of single use and/or the use of a needle size inappropriate to the type of procedure.Final conclusions from manufacturer: the tests performed allow the manufacturer to set aside a failure of the cannula.Considering the above investigation, the needle breakage seems to be due to the non-observance of the ifu, especially 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 other potential causes listed above in the analysis cannot be set aside.No similar complaint has been received on this needle batch out of (b)(4) needles sold.

• 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: 7447827
• MDR Text Key: 106142984
• Report Number: 0001721729-2018-00005
• 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
• Report Date: 03/27/2018,05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 02N2301
• Device Lot Number: F06553AA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/22/2018
• Event Location: Other
• Date Report to Manufacturer: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 41 YR