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

Model Number	MAXP301T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
In this event it is reported that a pro-rinse 30g maxp301t broke during use.No injury occurred.
Additional Manufacturer Narrative
Adding udi # - udi# (b)(4).This is a follow up report for this information.Investigation summary: 196 pro-rinse max i probes 30ga were returned ((b)(4) unsealed probes + (b)(4) 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
• Common Device Name: 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: 16823668
• Report Number: 2320721-2023-00243
• Device Sequence Number: 12430055
• Product Code: EIC
• UDI-Device Identifier: D716MAXP301T1
• UDI-Public: D716MAXP301T1
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown