MAUDE Adverse Event Report: SOFIC SAS HS DENTAL NEEDLE 27GA LONG PLASTIC

Catalog Number 02N1272

Device Problems Loss of or Failure to Bond (1068); Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/26/2018

Event Type  Injury  

Event Description

Spontaneous report from (b)(6), (b)(4).Local distributor ((b)(4)) reference (b)(4) (quality complaint was opened).Initial information received on 30-apr-2018 (quality complaint with incident was reported without adverse event) and follow-up 1 information received on 07-may-2018 by septodont over phone (serious adverse event was reported).The dentist reported that after performing the injection with suspected device (b)(4)standard needles 27g long (batch # f06477aa, expiration date: 2022-06) on an unspecified patient (gender and age unspecified) on (b)(6) 2018, the needle was no longer attached to the hub of the syringe whereas the dentist was recapping.When looked into the patient's mouth the dentist saw the needle was still in the patient's tissue.The procedure being performed was oral surgery.The patient was having a tooth removed.On an unspecified date, the dentist removed the needle from the patient's mouth successfully.At the time of this report, the patient's outcome was recovered.Samples are indicated to be returned for investigation.Causality assessment on 24-may-2018 on initial information received on 30-apr-2018 and additional information received on 07-may-2018: a.Seriousness: serious (pt foreign body in gastrointestinal tract: required intervention to prevent permanent impairment/damage (devices)).B.Expectedness: needle issue: unexpected ca/us; foreign body in gastrointestinal tract: unexpected ca/us.Product quality issue: unexpected ca/us.C.Causality a) latency - compatible.B) recognized association - no.C) analysis - during a dental procedure in a patient, the needle got stuck in the patient's mouth while using the medical device then removed by the dentist successfully.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 patient's anxiety or needle defect.Investigation on the product is pending.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

No abnormality was recorded on the affected batches of glue and cannula.Moreover the affected batches of glue and cannula were delivered to us with a certificate stating the compliance with the technical specifications.A) inspection of the glue point on the needles: 100 needles from sofic retained samples were examined to the naked eye in order to check the glue point.The 100 needles examined show sufficient quantity of glue.The inspection of the returned non-used 76 needles shows that the glue point is not visible on one needle.As for the incriminated needle, a low quantity of glue can be seen on it.B) dynamometer tests: 20 needles taken from sofic retained samples were submitted to a pull test to check the behavior of the cannula on the hub.All the values recorded during the test are higher than the minimum value defined by the iso 7885 standard "dentistry - sterile injection needles for single use".The same test was performed on the returned needle for which the glue point is not visible.The value obtained also complies with standards requirements.A maintenance intervention occurred during the production of this batch following a deficiency related to glue setting reported on production records.Routine controls carried out before and after the maintenance action did not detect defective products.Final conclusions from manufacturer: given above investigation and the needle in question, the reported issue is due to an occasional deficiency of glue setting during manufacturing of this batch.The occurrence of the defect is low as: controls carried out every 15 minutes during production of the batch are conform.No other complaint was received on this batch out of (b)(4) needles sold.

Event Description

Follow-up information received on 26-jul-2018 from quality department provided information regarding results of investigation.Additional information provided regarding results of investigation.Given above investigation and the needle in question, the reported issue is due to an occasional deficiency of glue setting during manufacturing of this batch.The occurrence of the defect is low as: controls carried out every 15 minutes during production of the batch are conform.No other complaint was received on this batch out of (b)(4) needles sold.File completed.Causality assessment re-evaluated on 30-jul-2018 on additional information received on 26-jul-2018: a.Seriousness: serious (pt foreign body in gastrointestinal tract: required intervention to prevent permanent impairment/damage (devices).B.Expectedness: needle issue: unexpected ca/us; foreign body in gastrointestinal tract: unexpected ca/us.Product quality issue: unexpected ca/us.C.Causality: a) latency: compatible.B) recognized association: no.C) analysis: during a dental procedure in a patient, the needle got stuck in the patient's mouth while using the medical device then removed by the dentist successfully.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.Quality investigations enhanced the needle issue causality.A new glue is currently under implementation by the manufacturer.However the other causes cannot be excluded.Therefore the causal relationship between the device and the events was considered as probable.D) dechallenge: na.E) rechallenge: na.Concluded causality who: probable.Follow-up 2 (result of investigation): based on quality investigation results the causal relationship was changed from not assessable to possible.Concluded causality who: probable.

• Brand Name: HS DENTAL NEEDLE 27GA LONG PLASTIC
• Type of Device: HS DENTAL NEEDLE
• Manufacturer (Section D): SOFIC SAS; 3, rue jean-jacques rousseau; aussillon; mazamet cedex, 81207 ; FR 81207
• MDR Report Key: 7573170
• MDR Text Key: 110202241
• Report Number: 3002987375-2018-00006
• 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: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 02N1272
• Device Lot Number: F06477AA
• 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: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention