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 09/25/2018

Event Type  Injury  

Event Description

Spontaneous report, from the u.S.(b)(4).Initial information received on (b)(4) 2018; follow-up #1 information was received on (b)(4) 2018; follow-up #2 information was received on (b)(4) 2018.Initial, follow-up #1, and follow-up #2 information received are integrated in below case narrative.The suspect device henry schein premium 30ga short needles (batch #1: f04497aa, expiration date: 2020-10; batch #2: f07144aa, expiration date: 2023-02) was used for injection during a dental filling procedure on two adult patients (gender and age unspecified), on either (b)(6) 2018.The syringe type used was screw-on type.No issues were reported while screwing the suspect needle onto the syringe.On (b)(6) 2018, during the injection, the hub and the needle cannula disconnected, with the needle hub stay connected to the syringe while the whole needle cannula stayed behind in the patient.No needle was reported broken.The dentist was able to retrieve the needle from the patient's mouth.Needle samples were expected to be returned for investigation.Causality assessment on (b)(4) 2018 on initial information and additional information received on (b)(4) 2018 and follow-up information received on (b)(4) 2018.Seriousness: serious (required intervention to prevent permanent impairment/damage (devices)).Expectedness: foreign body in gastrointestinal tract: unlisted eu, unexpected us/ca; needle issue: unlisted eu, unexpected us/ca.Causality: latency: suggestive.Recognized association: no.Analysis: in this case, the cannula of the needle has detached from the hub during a buccal injection for two patients with the same practitioner.Quality investigation is ongoing.At the time of this report, information was not sufficient to allow a causality assessment.Pending the results of quality control, the case report was considered as not assessable.Concluded causality who: not assessable.

Manufacturer Narrative

13 batches have been received for this complaint (including 1 from another needle manufacturer) whereas only 2 batches were specified in the initial complaint.The product ifu mentions not to remove the needles from their initial package before use, as mixing different batch numbers leads to a lack of visibility that may cause the use of expired needles.The batch records were reviewed for the 2 batches mentioned in the complaint, f04497aa & f07144aa.No fault relative to this type of issue was recorded on production and inspection records.For the 12 batches returned, the absence of non-conformance was checked in the different databases.No fault relative to this type of issue and no maintenance intervention were recorded.No other similar complaint was received on each of the 12 batches involved.11 needles from the 129 returned from batch: f07144aa mentioned by the complaint evidence an absence of visible glue point.The other needles examined from the batches produced by sofic (all needles returned from the remaining 11 batches and reserve samples of batches: f04497aa and f07144aa) evidence the presence of the glue point.Pull tests to check the resistance of the cannula at the glue point were carried out by sofic in the frame of this complaint on each of the 12 batches involved, i.E.On 25 needles per batch taken from the returned samples, and when needed, from our reserve samples.22 newtons is the minimum value defined by the iso 7885 standard "dentistry - sterile injection needles for single use" for the hold of the cannula at the glue point.For 11 batches, the tested needles comply with the requirements of iso 7885 (hold 22n).1 needle from batch: f07144aa does not comply with the requirements of iso 7885.The batches of glue used to manufacture these needles were delivered to us with a certificate stating the compliance with the technical specifications.If the issue of resistance at the glue point was related to the quality of glue, the occurrence of the defect would be higher.In the absence of recurrence recorded for this type of issue on this batch, it is likely that the problem is related to a temporary failure of glue setting, which did not require intervention to resume normal functioning and that given production speed, could not be identified during routine controls.Conclusion: the present investigation has evidenced a defect of holding of cannula on hub on some needles from batch: f07144aa.This issue is due to insufficient quantity of glue.Nevertheless, neither deviation nor maintenance intervention relative to this issue were recorded on the production records or in the databases.In the absence of recurrence recorded for this type of issue on this batch, it is likely that the problem is related to a temporary failure of glue setting, which did not require intervention to resume normal functioning and that given production speed, could not be identified during routine controls.Risk assessment concerning needle batch#: f07144aa is ongoing at the time of this follow-up report.A follow-up mdr will be submitted to authorities once the risk assessment for needle batch#: f07144aa is completed by the company.

Event Description

Quality investigation results was received on 11-feb-2019.Needle samples were returned for investigation on 15-oct-2018.It is noted that in addition to samples from the two suspect needle batches, 10 other needle batches were also returned to the manufacturer for investigation: f06553aa, f04097aa, f06893aa, f04583aa, f04419aa, f03919aa, f05511aa, f04265aa, f06126aa, f05818aa.9h130308 (confirmed by manufacturer that this needle batch is not a device made by the manufacturer, hence investigation could not be performed on this batch).Hence, the manufacturer performed quality investigation on all 12 returned needle batches.The present investigation has evidenced a defect of holding of cannula on hub on some needles from batch: f07144aa.This issue was due to insufficient quantity of glue.Nevertheless, neither deviation nor maintenance intervention relative to this issue were recorded on the production records or in the databases.In the absence of recurrence recorded for this type of issue on this batch, it is likely that the problem is related to a temporary failure of glue setting, which did not require intervention to resume normal functioning and that given production speed, could not be identified during routine controls.Causality assessment re-evaluated on 11-mar-2019 on additional information received on 11-feb-2019: a.Seriousness: serious (required intervention to prevent permanent impairment/damage (devices).B.Expectedness: foreign body in gastrointestinal tract: unlisted eu, unexpected us/ca; needle issue: unlisted eu, unexpected us/ca.C.Causality: a) latency: suggestive.B) recognized association: no.C) analysis: in this case, the cannula of the needle has detached from the hub during a long buccal injection for two patients with the same practitioner.The reporter experienced the same event with three different patients, without knowing if it was with the same batch of needles.Among the several received and tested batches, the investigation evidenced a defect of holding of cannula on hub on the batch: f07144aa as the glue that ensure the liaison between the canula and the hub may be insufficient.As a precautionary measure, the causal relationship between the device and the events was assessed as probable, considering that the defective batch may have been used in these patients.D) dechallenge: na.E) rechallenge: na.Concluded causality who: probable.Quality investigation results received on 11-feb-2019: assessment changed from not assessable to probable.

Manufacturer Narrative

Supplement to the manufacturer narrative: investigation was performed on batch f07144aa: this is the first complaint ever received for needle batch f07144aa to date since its manufacturing in april 2018.The present investigation has evidenced a defect in the holding of the cannula on the hub on (b)(4) of the (b)(4) needles returned by the practitioner from batch f07144aa, which consists of (b)(4) loose needles and (b)(4) unused box of (b)(4) needles.As the defective needle was only detected from the (b)(4) loose needles returned and not from the unused box, and in absence of other product quality complaint and adverse incident reported for batch f07144aa, it is reasonable to conclude that all needles with the suspected defect are localized to one single box of needles.Visual inspection of the retention samples and the needles in the unused box indicated that all needles have sufficient quantity of adhesive applied.Additionally, pull test results from retention samples all conformed to iso 7885 requirements (>22 newtons).Batch review: all components and materials met their respective release criteria prior to being consumed for the manufacturing into batch f07144aa.A review of the complaint histories of all other batches in which the same lots of adhesive and needle cannula were used showed no similar complaints or issues of cannula adhesion / detachment from the hub.During the adhesive application and glue setting processes, there were no adhesive application related issues identified.Visual monitoring of the adhesive application station and glue setting station by operators for the entire duration of the adhesive application and glue setting steps did not evidence any deviation.All manufacturing processes were followed without deviations.Additionally, no maintenance service to the adhesive application or glue setting station was required, which evidenced proper functioning of the adhesive application and glue setting stations during the manufacturing process of f07144aa.In process checks for failure of adhesive application and glue setting occurred at 15-minute intervals.These included visual inspection of sampled needles (including cannulas) for any evidence of inadequate adhesive and needle hubs without cannula.In addition a pull test was performed on the sampled needles.There were no observations during in process checks performed on the needles following the glue setting process and the individual pull test values for all tested needles met iso 7885 specifications of no less than 22 n.Finished products testing performed prior to release of f07144aa met all specifications, including pull test values complying with iso 7885 requirements.Discussion root cause: batch record review revealed no irregular equipment or component issues during the manufacture of needle batch f07144aa.All manual, in-process testing of needles following the glue setting step that were performed throughout the batch met expectations and all finished product test results were within specifications.Testing of retention samples all met specifications.It is therefore reasonable to conclude that the most probable root cause to the reported needle cannula detachment issue was due to an inadequate amount of adhesive applied during the adhesive application process contained in an extremely isolated portion of the batch.Disposition: at the time of this writing, f07144aa has been in the market for 11 months with only 4 suspected needle detachments from the hub occurrences and all of these originated from the same reporting dentist.Therefore, there is no evidence to suggest that there was any systemic quality issue with the manufacturing process.It is acknowledged that the unexpected detachment of the needle cannula from the hub may incur a risk to the patient as intervention to remove the detached hub from the tissues is required.Although reported, all reported concerns of this nature were received from a single dental practitioner and no other similar complaints have been received for needle batch f07144aa, which is indicative that the reported concern was extremely limited, perhaps contained in one single box of product and is not a representative sample of quality for batch f07144aa.Accordingly, given the isolated nature of the glue setting issue, no field action is required at this time.However, enhanced monitoring of any complaint or other incidents involving this batch will be performed.Conclusion: the present investigation has evidenced a defect of the holding of the cannula on the hub on 1 of the 129 needles returned by the practitioner from batch f07144aa, which consists of (b)(4) loose needles and (b)(4) unused box of (b)(4) needles.As the defective needle was only detected from the (b)(4) loose needles returned and not from the unused box, and in absence of other product quality complaint and adverse incident reported, all needles with the suspected defect seem to have been localized to the same box of needles.A review of the batch record for batch f07144aa did not highlight any unusual incidents or observations that could be associated with the reported defect and no complaints of a similar nature were received for this batch to date.All other product from batch f07144aa remained unaffected.This investigation has concluded that the most probable root cause to the reported needle cannula detachment issue was due to inadequate amount of adhesive applied during the adhesive application process contained in an extremely isolated portion of the batch and that there is no basis for field action at this time.This complaint does not represent a systemic concern with the batch.Enhanced monitoring of any complaints or other incidents involving batch f07144aa will be performed.

Event Description

Supplement to the manufacturer narrative received from manufacturer on (b)(6)2019.Refer to manufacturer narrative for details.

• 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: 8011055
• MDR Text Key: 125278402
• Report Number: 3002987375-2018-00010
• 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,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 02N2301
• Device Lot Number: F07144AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Date Manufacturer Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention