BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® BLUNT FILL NEEDLE

    MDR report key: 17436007 · Received August 1, 2023

    Report

    Report Number
    3002682307-2023-00221
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 14, 2023
    Report Date
    September 15, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903031290
    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: 15-AUG-2023. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBERS 230113 AND 230104. 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, THREE (3) PHYSICAL SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SAMPLES WERE VISUALLY EXAMINED AND NO SIGNS OF DEFECT WERE OBSERVED. THE NEEDLES THEN WERE USED TO PUNCTURE A TEST VIAL AND WERE THEN MICROSCOPICALLY EXAMINED WITH NO ISSUES IDENTIFIED. BASED ON THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT THE CORING EFFECT RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA DURING MANUFACTURE. AS THIS PRODUCT HAS A SHORT BEVEL, IT SHOULD PENETRATE THE STOPPER AT A NINETY-DEGREE ANGLE TO MINIMIZE THE RISK OF CATCHING THE INTERNAL WALL OF THE VIAL STOPPER. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. 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 · 0

    IT WAS REPORTED WHILE USING BD® BLUNT FILL NEEDLE FOREIGN MATTER CAUSED A BLOCKAGE IN THE NEEDLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: I WOULD LIKE TO INFORM YOU OF A NEW INCIDENT IN THE USE OF THE LOADING NEEDLE, CODE 903099, REFERENCE 303129 OF LOTS 230113 AND 230104. WHEN DILUTING AN ANTIBIOTIC, A PIECE OF RUBBER REMAINED IN THE NEEDLE, OBSTRUCTING AND IMPEDING THE PASSAGE OF THIS DILUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD® BLUNT FILL NEEDLE FOREIGN MATTER CAUSED A BLOCKAGE IN THE NEEDLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: I WOULD LIKE TO INFORM YOU OF A NEW INCIDENT IN THE USE OF THE LOADING NEEDLE, CODE 903099, REFERENCE (B)(4) OF LOTS 230113 AND 230104. WHEN DILUTING AN ANTIBIOTIC, A PIECE OF RUBBER REMAINED IN THE NEEDLE, OBSTRUCTING AND IMPEDING THE PASSAGE OF THIS DILUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335310 BD® BLUNT FILL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 230104 00382903031290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown