MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PRO-RINSE 30G MAXP301T; SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

Model Number MAXP301T

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

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 device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it is reported that pro-rinse 30g maxp301t probe broke during use.No injury occurred.

Manufacturer Narrative

Summary: 73 unused pro-rinse max i probes 30ga were returned.The probes that broke during use were not returned and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #(b)(6)).Unused probes were tested (tensile strength test).Findings (between 47.90n and 85.10n) are beyond the minimal requirement of 26.7n.No fault was found with the returned products.

• Brand Name: PRO-RINSE 30G MAXP301T
• Type of Device: SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17208701
• MDR Text Key: 317937979
• Report Number: 2320721-2023-00257
• Device Sequence Number: 1
• Product Code: EIC
• UDI-Device Identifier: D716MAXP301T1
• UDI-Public: D716MAXP301T1
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MAXP301T
• Device Catalogue Number: MAXP301T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/26/2023
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1