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

Catalog Number 606.20.118

Device Problem Component Missing (2306)

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.The returned syringe is empty.Remains of amine paste and epoxy paste can be recognized in both cannulas.The customer has sent in the pressed out material which is exclusively amine paste.A dhr review was conducted with no discrepancies noted.

Event Description

In this event it was reported that only the white paste was filled in an ah plus jet syringe and the brown (catalyst) paste was missing.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: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 8596252
• MDR Text Key: 151941165
• Report Number: 8010638-2019-00006
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 606.20.118
• Device Lot Number: 1806000796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1