BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG CLEAR SDZ

    MDR report key: 12021159 · Received June 17, 2021

    Report

    Report Number
    3009081593-2021-00029
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 5, 2021
    Report Date
    July 8, 2021
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR DEFECTIVE SAFETY DEVICE DETECTED DURING CUSTOMER PROCESS. MEASUREMENT REPORT AND PHOTOS WERE PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. BASED ON THE INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS. BD COULD NOT CONFIRM THE REPORTED CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ULTRASAFE X100L PNG CLEAR SDZ PLUNGER ROD MOVEMENT WAS BLOCKED. THIS OCCURRED ON 16 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING DESIGN VERIFICATION TESTING OF A COMBINATION PRODUCT COMPRISING THE X100L NEEDLE GUARD AND X100L PLUNGER ROD (TRANSPARENT) A GROUP OF 16 SAMPLES OUT OF 61 RESULTED IN HIGHER THAN EXPECTED ACTIVATION FORCE (AROUND 20N WHEREAS EXPECTED AROUND 10N). TWO SAMPLES EVEN EXCEEDED THE SPECIFICATION LIMIT OF 30N. THE OPERATOR PERFORMING THE TESTING NOTICED THAT THE SAMPLES WITH HIGHER ACTIVATION FORCE SHOWED UNUSUAL BEHAVIOR OF GUARD WINGS. THESE GOT BENT, WHEN PUSHED BY THE PLUNGER ROD AND ONLY MOVED TO THE CORRECT DIRECTION AFTER HIGHER FORCE WAS APPLIED. THE GUARD WINGS OF THE TWO SAMPLES, WHICH FAILED THE SPECIFICATION, DID NOT MOVE TO THE RIGHT DIRECTION AT ALL AND THE WINGS GOT DAMAGED.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: K011369, K122558. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ULTRASAFE X100L PNG CLEAR SDZ PLUNGER ROD MOVEMENT WAS BLOCKED. THIS OCCURRED ON 16 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING DESIGN VERIFICATION TESTING OF A COMBINATION PRODUCT COMPRISING THE X100L NEEDLE GUARD AND X100L PLUNGER ROD (TRANSPARENT) A GROUP OF 16 SAMPLES OUT OF 61 RESULTED IN HIGHER THAN EXPECTED ACTIVATION FORCE (AROUND 20N WHEREAS EXPECTED AROUND 10N). TWO SAMPLES EVEN EXCEEDED THE SPECIFICATION LIMIT OF 30N. THE OPERATOR PERFORMING THE TESTING NOTICED THAT THE SAMPLES WITH HIGHER ACTIVATION FORCE SHOWED UNUSUAL BEHAVIOR OF GUARD WINGS. THESE GOT BENT, WHEN PUSHED BY THE PLUNGER ROD AND ONLY MOVED TO THE CORRECT DIRECTION AFTER HIGHER FORCE WAS APPLIED. THE GUARD WINGS OF THE TWO SAMPLES, WHICH FAILED THE SPECIFICATION, DID NOT MOVE TO THE RIGHT DIRECTION AT ALL AND THE WINGS GOT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913158 ULTRASAFE X100L PNG CLEAR SDZ PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) 0229373

    Patients

    Seq Age Sex Outcome Treatment
    1