BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X1-1/2 RB

    MDR report key: 18594864 · Received January 29, 2024

    Report

    Report Number
    1911916-2024-00042
    Event Type
    Malfunction
    Date Received
    January 29, 2024
    Date of Event
    January 16, 2024
    Report Date
    February 15, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051275
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED MEDICATION WAS LEAKING AROUND THE HUB. TO AID IN THE INVESTIGATION, FIVE SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. NO LEAKAGE WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305127, LOT 3083311. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED  MATERIAL #: 305127 BATCH#: 3083311 IT WAS REPORTED BY CUSTOMER THAT DEFECTIVE NEEDLE CONCERN VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. BD PRECISIONGLIDE NEEDLE 25G X 11/2" TW (0.5MM X 40MM) REF (B)(4) BECKTON, DICKINSON AND COMPANY LOT 3083311 DEFECTIVE NEEDLE CONCERN ADDITIONAL INFORMATION FROM EMAIL CHAIN: BD PRECISIONGLIDE NEEDLE 25G X 11/2" TW (0.5MM X 40MM) REF (B)(4) BECKTON, DICKINSON AND COMPANY LOT 3083311 GOOD MORNING, I WAS ASSISTING DR. (B)(6) IN CLINIC THIS AFTERNOON (B)(6) 2024. HE WAS PERFORMING AN US GUIDED INJECTION INTO A PATIENT'S FOOT. WE NOTICED THAT THE NEEDLE HE HAD INSERTED INTO THE PATIENT WAS LEAKING MEDICATION AROUND THE HUB INSTEAD OF THROUGH THE END OF THE NEEDLE TIP. HE WITHDREW THE NEEDLE AND TIGHTENED THE NEEDLE ONTO THE SYRINGE MAKING SURE IT WAS FIRM. HE INSERTED THE NEEDLE AGAIN AND PUSHED THE PLUNGER TO INSERT THE MEDICATION. WE THEN NOTICED THAT THE LIQUID WAS COMING OUT FROM A SMALL HOLE ON THE SIDE OF THE HUB. THE MEDICATION FROM THE SMALL HOLE MADE AN AUDIBLE HISSING SOUND. HE WITHDREW THE NEEDLE AND I ASSISTED OPENING A NEW NEEDLE AND PLACED ONTO THE SYRINGE SO THAT HE COULD COMPLETE THE PROCEDURE. I ALSO NOTICED A CONCERN LAST WEEK DURING A PROCEDURE WHEN I OPENED AND DROPPED THE SAME EXACT TYPE OF NEEDLE ONTO A STERILE PROCEDURE TRAY. THE NEEDLE FELL ONTO THE PROCEDURE TRAY AND I NOTICED A VERY SMALL PIECE OF BLUE PLASTIC. UPON CLOSER EXAMINATION; I COULD SEE THAT THE BLUE HUB HAD A CHIP IN IT. FORTUNATELY THE DEFECTIVE NEEDLE WAS SEEN PRIOR TO USE. I BELIEVE THAT BOTH OF THESE NEEDLES ARE FROM THE SAME LOT AND WANTED TO INFORM YOU KNOW ABOUT THE ISSUE. I HAVE COPIED MY NURSE MANAGER ON THIS EMAIL. PLEASE LET US KNOW HOW YOU WOULD LIKE TO PROCEED. BOTH OF THE DEFECTIVE NEEDLES WERE PULLED FROM THE FRISCO SPORTS MEDICINE SUPPLY CLOSET ON THE SECOND FLOOR #(B)(6).

    Description of Event or Problem · 0

    THIS MDR IS FOR THE HOLE IN THE HUB MATERIAL #: 305127 BATCH#: 3083311 IT WAS REPORTED BY CUSTOMER THAT DEFECTIVE NEEDLE CONCERN VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. BD PRECISIONGLIDE NEEDLE 25G X 11/2" TW (0.5MM X 40MM) REF 305127 BECKTON, DICKINSON AND COMPANY LOT 3083311 DEFECTIVE NEEDLE CONCERN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649377 NEEDLE 25X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3083311 30382903051275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown