BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 20852480 · Received December 5, 2024

    Report

    Report Number
    1911916-2024-00873
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    November 20, 2024
    Report Date
    December 19, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. ADDITIONAL BATCHES REPORTED: BATCH: 4116510; BATCH CREATION DATE: 2024-04-25; BATCH EXPIRATION DATE: 2029-06-30; FULL UDI: (B)(4). BATCH: 3271790; BATCH CREATION DATE: 2023-09-28; BATCH EXPIRATION DATE: 2028-10-31; FULL UDI: (B)(4). BATCH: 4081033; BATCH CREATION DATE: 2024-03-21; BATCH EXPIRATION DATE: 2029-05-31; FULL UDI: (B)(4). BATCH: 3209276; BATCH CREATION DATE: 2023-07-28; BATCH EXPIRATION DATE: 2028-09-30; FULL UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP. IT WAS REPORTED THE NEEDLES HAVE NO LUMEN. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305106 AND LOT NUMBERS 4116510, 3271790, 4081033, 3209276 AND 3236002. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    MATERIALS: 305106; BATCH#: 4116510, 3271790, 4081033, 3209276, 3236002. IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE WAS DEFECTIVE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE RECEIVED THE FOLLOW PRODUCT QUALITY REPORT FROM ONE OF OUR OPHTHALMOLOGISTS FOR BD PRECISION. GLIDE NEEDLE 30G X1/2 REF# 305106. HERE IS THE PHYSICIAN REPORT OF THIS CONCERN: ¿I GAVE A BAG OF NEEDLES I'VE COLLECTED THAT WEREN¿T ACTUALLY NEEDLES, THEY¿RE PINS. THEY HAVE NO LUMEN SO NOTHING CAN BE PUSHED THROUGH THEM. IT SEEMS TO HAPPEN RANDOMLY AND FROM MANY DIFFERENT LOTS. ESSENTIALLY, IT¿S AN EROSION OF THEIR QUALITY CONTROL. I¿D NEVER ENCOUNTERED THIS UNTIL THE PAST YEAR OR TWO. I WOULD ASK THEM FOR A REFUND FOR AT LEAST ONE BOX WORTH OF NEEDLES THAT HAVE BEEN UNUSABLE, BUT MORE IMPORTANTLY ASSURANCE THEY ARE IMPROVING THEIR PROCESS SO THIS STOPS HAPPENING. OTHERWISE, WE SHOULD SWITCH VENDORS TO A RELIABLE PRODUCER. ON MONDAY I PUT A NEEDLE IN SOMEONE'S EYE AND TRIED TO INJECT MEDICINE AND IT SQUIRTED EVERYWHERE (IT WAS A SLIP TIP AND THE NEEDLE WAS IMPERFORATE). THAT PATIENT HAD TO HAVE A SECOND INJECTION WHICH DOUBLED THE RISK OF THE PROCEDURE. WE ALSO WASTED AN AVASTIN SYRINGE WHICH COSTS OUR ORGANIZATION HUNDREDS OF DOLLARS. ALL BECAUSE THE NEEDLE WAS DEFECTIVE. OUR PATIENTS DESERVE BETTER."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977510 NEEDLE 30X1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3236002 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown