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 04/26/2023

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 broke during use.No injury occurred.

Manufacturer Narrative

Adding udi # (b)(4), this is a follow up report to add the udi #.Summary: 196 pro-rinse max i probes 30ga were returned (2 unsealed probes + 194 sealed probes).The two unsealed probes were observed and show no sign of use and no damage.The devices that broke during use were not returned and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #1783731).Unused probes were tested (tensile strength test).Findings (between 30.05n and 93.30n) 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: 16823233
• MDR Text Key: 314090010
• Report Number: 2320721-2023-00239
• 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: 07/19/2023

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 Model Number: MAXP301T
• Device Catalogue Number: MAXP301T
• Device Lot Number: 1775628
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/26/2023
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1