MAUDE Adverse Event Report: DENTSPLY DETREY GMBH AH PLUS JET; RESIN, ROOT CANAL FILLING

Catalog Number 606.20.118

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

While no serious injury resulted, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.In the complaint syringe is only the epoxide cannula filled with material.In the ifu is described: to ensure appropriate mixing, the customer must bleed the syringe prior to the first use.Here, the customer notices that only one cannula is filled with material.This is a syringe that was used to set up the filling machine, which accidentally went on sale.In (b)(4) 2018 there was an adjustment of the filling instructions in which these syringes, which are used for setting up, will be marked.If this syringe should be re-processed accidentally this syringe would be noticed in the packaging before applying the label and will be discarded.Because the lot number of the complaint syringe is (b)(4) 2017, the filling of this syringe was still before the conversion.A dhr review was conducted with no discrepancies noted.

Event Description

In this event it was reported that only paste b was coming out of an ah plus jet syringe.The syringe was bled prior to use on any patients and the issue was discovered at that time.

• Brand Name: AH PLUS JET
• Type of Device: RESIN, ROOT CANAL FILLING
• Manufacturer (Section D): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz, 78467 ; GM 78467
• Manufacturer (Section G): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz, 78467 ; GM 78467
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 7643384
• MDR Text Key: 112562682
• Report Number: 8010638-2018-00005
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K960548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 606.20.118
• Device Lot Number: 1712000913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1