BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIDI PRODUCTS LLC, PEN BLADE

    MDR report key: 13026665 · Received December 17, 2021

    Report

    Report Number
    2182318-2021-00014
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    November 8, 2021
    Report Date
    March 10, 2022
    Manufacturer
    TIDI PRODUCTS, LLC
    Product Code
    GDX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6: WHILE THIS PART NUMBER IS NOT USED IN MEDICAL SETTINGS, IT IS THE SAME OR SIMILAR TO ITS STERILE MEDICAL BLADE COUNTERPART AND THEREFORE COULD EXPERIENCE A SIMILAR DEFECT. INTERFERENCE TESTING HAS DETERMINED IT LIKELY THAT THE SHELL RAILS ARE INTERFERING WITH THE SLIDE AND CAUSING THE DEVICE TO DELAY AND OR NOT RETRACT. ADDITIONALLY, THERE WAS A SINGLE INSTANCE OF THE BLADE CONNECTION RUBBING AT THE DISTAL TIP OF THE HOUSING. THE LATEST SLIDE MOLD MODIFICATION WAS IMPLEMENTED, MODIFYING THE RAILINGS TO DECREASE INTERFACING WITH THE SLIDE, AFTER THESE UNITS WERE BUILT TO MITIGATE THIS INTERFERENCE BY REDUCING THE PLASTIC BUILD UP ALONG THE BLADE CONNECTION. THIS SLIDE MOLD WAS VERIFIED AND MET ALL PRODUCT SPECIFICATIONS. THIS FAILURE MODE HAS BEEN NOTED HISTORICALLY AND ACTIONS HAVE BEEN TAKEN TO DECREASE THE RATE OF FAILURE. FURTHER TESTING IS CURRENTLY BEING CONDUCTED ON DIFFERENT SAMPLE POPULATIONS TO INVESTIGATE THE FACTORS LEADING TO DELAYED RETRACTION OR NO RETRACTION. NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT WAS RETURNED FOR EVALUATION. HOWEVER, THE RESULTS OF THE INVESTIGATION ARE PENDING. NOTE THAT THIS SPECIFIC PART NUMBER IS NOT SOLD AS FOR USE IN MEDICAL SETTINGS. IT IS SAME OR SIMILAR DESIGN TO STERILE MEDICAL BLADES ALSO SOLD BY TIDI AND THEREFORE COULD EXPERIENCE A SIMILAR DEFECT. IF THE PRODUCT DOESN'T RETRACT AS INTENDED, THEN THE PRODUCT IS PUTTING CLINICIANS AT RISK FOR A SHARPS INJURY EVEN THOUGH OTHER SAFETY PRACTICES ARE IN PLACE. HISTORICAL COMPLAINT DATA REVIEW FOUND TWO OTHER SIMILAR COMPLAINTS DOCUMENTED FOR THIS PRODUCT IN THE LAST TWO YEARS. A CAPA THAT WAS OPENED AT THAT TIME IDENTIFIED THE ROOT CAUSE OF THE NONCONFORMANCE TO BE AN INADEQUATE OR DEFECTIVE MOLD DESIGN OF THE SLIDE, WITH DEFECTIVE UNITS EXHIBITING EXCESSIVE MATERIAL ON THE SLIDE/BLADE CONNECTION. CORRECTIVE ACTION WAS TO CHANGE THE SLIDE MOLD DESIGN. IMPLEMENTATION OF CORRECTIVE ACTIONS WAS COMPLETED IN AUGUST OF 2020. LOT INFORMATION IS NOT AVAILABLE AT THIS TIME, THEREFORE MANUFACTURING DOCUMENTATION COULD NOT BE PULLED FOR REVIEW. IT IS POSSIBLE THAT THESE UNITS WERE MANUFACTURED BEFORE CORRECTIVE ACTION WAS FULLY IMPLEMENTED. INVESTIGATION AND EVALUATION OF RETURNED PRODUCT IS IN PROCESS. NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY AT PRESENT. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY CADENCE. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED, AND ACTED UPON AS APPROPRIATE. MANUFACTURER REFERENCE FILE # (B)(4).

    Description of Event or Problem · 0

    EMAIL AND CALL FROM CUSTOMER HAS 175 EACHES WITH BLADES THAT ARE STUCK AND NON-RETRACTABLE. SUPPLEMENTAL MEDWATCH BEING SENT FOR ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    EMAIL AND CALLED FROM CUSTOMER HAS 175 EACHES WITH BLADES THAT ARE STUCK AND NON-RETRACTABLE. WANTS 175 EACH REPLACEMENT. ALL 175 IN SOME MASTER CARTONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921733 TIDI PRODUCTS LLC, PEN BLADE SCALPEL, ONE-PIECE GDX TIDI PRODUCTS, LLC PBNS11ACTN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown