BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE

    MDR report key: 8021494 · Received October 30, 2018

    Report

    Report Number
    2243072-2018-01544
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 11, 2018
    Report Date
    January 18, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THREE BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE HAD RESTRICTED FUNCTION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. INVESTIGATION SUMMARY: CUSTOMER RETURNED (3) BD BLUE/BLACK SAFE-CLIPS (2 FROM LOT # 7322556 AND 1 FROM LOT # 7173530). SEVERITY RANKING IS S1. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 7322556 AND 7173530. DHR¿S WERE REVIEWED AND IT HAS BEEN FOUND THAT THE MATERIAL WAS PRODUCED PRIOR TO NHB1 TRANSFER TO NHB2. DHR¿S SHOW THAT ALL PARTS COMPLY WITH QUALITY STANDARDS. SAMPLES WERE SENT TO NYPRO ON 9 NOVEMBER 2018 FOR FURTHER INVESTIGATION. INVESTIGATION CONCLUSION: NYPRO'S INVESTIGATION FINDINGS' SUMMARY WERE RECEIVED ON 16 JANUARY 2019. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. THE RETURNED SAFE-CLIPS WERE EXAMINED UNDER MICROSCOPE AND OBSERVED TO HAVE THE CUTTING HOLE CLEAN, NOT BLOCKED WITH NEEDLES. ALL THREE WERE ABLE TO CUT NEEDLES BUT THEY ALL FEEL A BIT 'STUCK' WHEN OPENING AND CLOSING. OPENING AND CLOSING IS NOT SMOOTH. RETAIN SAMPLES WERE REVIEWED AND THE SAMPLES DID NOT PRESENT THE REPORTED CONDITION, PARTS OPENED AND CLOSED WITH NO ISSUE. DURING THE PRELIMINARY INVESTIGATION IT WAS FOUND THAT THE POSITION OF THE BLADE WAS INCORRECT DUE THAT THE PRESS MECHANICAL STOPPER WAS MALADJUSTED, DURING PREVIOUS INVESTIGATION THE FUNCTIONAL TEST OF THE PART WAS INCREASED FROM 1 TO 3 TIMES TO IMPROVE DETECTION, MEANWHILE FURTHER CORRECTIVE ACTIONS ARE BEING DETERMINE FOR THE MECHANICAL PRESS. ROOT CAUSE DESCRIPTION: THE POSITION OF THE BLADE WAS INCORRECT BECAUSE THE PRESS MECHANICAL STOPPER WAS MALADJUSTED. RATIONALE: THE VERIFICATION OF EFFECTIVENESS OF CORRECTIVE ACTIONS WILL BE MONITORED DURING PRODUCTION RUNS FOR 3 MONTHS AFTER ACTION IMPLEMENTATION MEANING SAMPLING PLAN WILL BE MODIFIED FORM 0.25 TO 0.15 AND REGISTERED IN DHR FOR EVIDENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE HAD RESTRICTED FUNCTION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS NYPRO. THIS SITE IS AN OEM MANUFACTURING SITE. 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 BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE HAD RESTRICTED FUNCTION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861340 BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE NEEDLE CIPPING DEVICE FMI BECTON DICKINSON 7322556 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other