BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® BLUNT FILL NEEDLE

    MDR report key: 17302940 · Received July 11, 2023

    Report

    Report Number
    3002682307-2023-00194
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    June 20, 2023
    Report Date
    September 12, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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: 02-AUG-2023 . H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBERS 230204, 221206, AND 220907. 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, TWO (2) PICTURE SAMPLES OF A SYRINGE PRODUCT AND FORTY (40) UNUSED NEEDLE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. ALL OF THE NEEDLE SAMPLES WERE TESTED (USING DIFFERENT ANGLES OF PENETRATION) WITH A LABORATORY VIAL WHICH HAD A PLASTIC STOPPER. NO DIFFICULTIES WERE OBSERVED DURING THE TESTING. AFTER VIAL PUNCTURE TESTING, THE NEEDLES WERE EXAMINED UNDER MICROSCOPE AND NO PARTICLES FROM VIAL STOPPER FRAGMENTATION WERE FOUND AND THE BEVELS REMAINED IN GOOD FORM. A DEFECT DIRECTLY RELATED WITH THE MANUFACTURING OF THE NEEDLE PRODUCT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 220907. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2027. H.4. DEVICE MANUFACTURE DATE: 01-SEP-2022. D.4. MEDICAL DEVICE LOT #: 221206. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2027. H.4. DEVICE MANUFACTURE DATE: 14-DEC-2022. D.4. MEDICAL DEVICE LOT #: 230204. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2028. H.4. DEVICE MANUFACTURE DATE: 30-JAN-2023. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH AN UNSPECIFIED AMOUNT OF BD® BLUNT FILL NEEDLE CORING OCCURS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN PRICKING WITH THIS NEEDLE A VIAL WITH RUBBER STOPPER, A FRAGMENT OF THE RUBBER WAS ASPIRATED AND DEPOSITED IN THE SYRINGE BY PUMP. THIS HAS HAPPENED TO US WITH DIFFERENT DRUGS, SO I THINK IT IS SO SERIOUS THAT WE MUST REVIEW ALL THE FACTORS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH AN UNSPECIFIED AMOUNT OF BD® BLUNT FILL NEEDLE CORING OCCURS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN PRICKING WITH THIS NEEDLE A VIAL WITH RUBBER STOPPER, A FRAGMENT OF THE RUBBER WAS ASPIRATED AND DEPOSITED IN THE SYRINGE BY PUMP. THIS HAS HAPPENED TO US WITH DIFFERENT DRUGS, SO I THINK IT IS SO SERIOUS THAT WE MUST REVIEW ALL THE FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233989 BD® BLUNT FILL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown