BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE

    MDR report key: 17082103 · Received June 7, 2023

    Report

    Report Number
    3002682307-2023-00151
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    May 16, 2023
    Report Date
    September 11, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 12-JULY-2023 . H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBER 230404. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, A LUER LOCK SYRINGE AND TWO (2) USED NEEDLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLES, A BLACK PARTICLE WAS OBSERVED WITHIN THE SYRINGE. THE NEEDLES WERE MICROSCOPICALLY EXAMINED; HOWEVER, NO SIGNS OF DAMAGE OR DEFECT WERE OBSERVED. ALTHOUGH THE PROVIDED FEEDBACK INDICATES AN ISSUE OF CORING EFFECT, THE INVESTIGATION RESULTS DID NOT IDENTIFY ANY POTENTIAL MANUFACTURING RELATED CAUSE FOR SUCH AN EVENT.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD¿ NEEDLES PUNCTURED THEIR VIALS/INFUSION BAGS AND CORED PIECES OF THE RUBBER INTO THE MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "WE ARE NOW EXPERIENCING GREAT INCONVENIENCE IN THE PHARMACY WHEN USING THESE NEEDLES: THEY BLUNT QUICKLY THEY PUNCTURE THE RUBBER OF THE VIALS/INFUSION BAGS, CAUSING PIECES OF RUBBER TO GET INTO THE VIAL OR INFUSION BAG."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD¿ NEEDLES PUNCTURED THEIR VIALS/INFUSION BAGS AND CORED PIECES OF THE RUBBER INTO THE MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "WE ARE NOW EXPERIENCING GREAT INCONVENIENCE IN THE PHARMACY WHEN USING THESE NEEDLES: THEY BLUNT QUICKLY THEY PUNCTURE THE RUBBER OF THE VIALS/INFUSION BAGS, CAUSING PIECES OF RUBBER TO GET INTO THE VIAL OR INFUSION BAG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367004 BD¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown