MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-06-27 for AH PLUS JET 606.20.118 manufactured by Dentsply Detrey Gmbh.
[112562682]
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.
Patient Sequence No: 1, Text Type: N, H10
[112562683]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010638-2018-00005 |
| MDR Report Key | 7643384 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-06-27 |
| Date of Report | 2018-06-27 |
| Date Mfgr Received | 2018-05-30 |
| Date Added to Maude | 2018-06-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DENTSPLY DETREY GMBH |
| Manufacturer Street | DETREY STRASSE 1 |
| Manufacturer City | KONSTANZ, 78467 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78467 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AH PLUS JET |
| Generic Name | RESIN, ROOT CANAL FILLING |
| Product Code | KIF |
| Date Received | 2018-06-27 |
| Returned To Mfg | 2018-06-06 |
| Model Number | NA |
| Catalog Number | 606.20.118 |
| Lot Number | 1712000913 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY DETREY GMBH |
| Manufacturer Address | DETREY STRASSE 1 KONSTANZ, 78467 GM 78467 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-27 |