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U.S. Department of Health and Human Services

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

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TULSA DENTAL PRODUCTS LLC PRO-RINSE 30G MAXP301T; SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING Back to Search Results
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 a pro-rinse 30g maxp301t broke during use.No injury occurred.
 
Manufacturer Narrative
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.Adding udi# - udi# (b)(4) this is a follow up report for this information.
 
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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 Key16823898
MDR Text Key314098445
Report Number2320721-2023-00244
Device Sequence Number1
Product Code EIC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 07/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberMAXP301T
Device Catalogue NumberMAXP301T
Device Lot Number1775628
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date04/26/2023
Date Manufacturer Received04/26/2023
Was Device Evaluated by Manufacturer? No
Type of Device Usage A
Patient Sequence Number1
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