BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® BLUNT FILL NEEDLE

    MDR report key: 17753118 · Received September 15, 2023

    Report

    Report Number
    3002682307-2023-00276
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 28, 2023
    Report Date
    February 27, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903031290
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4: MEDICAL DEVICE LOT #: 230519. D4: MEDICAL DEVICE EXPIRATION DATE: 30APR2028. H4: DEVICE MANUFACTURE DATE: 02MAY2023. H3: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBERS 230204 AND 230519. 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, ONE (1) PICTURE SAMPLE AND FIVE (5) PACKAGED NEEDLE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE NEEDLES WERE MICROSCOPICALLY EXAMINED AND NO IRREGULARITIES WERE IDENTIFIED WITH THE CANNULA COMPONENTS; THEREFORE, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE IDENTIFIED FOR THIS REPORTED DEFECT. BASED ON THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT CORING RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA. IT IS POSSIBLE THAT THE STOPPER CONDITIONS (ASK YOUR SUPPLIER FOR MATERIAL CHANGES AS WELL AS RECOMMENDATIONS OF STORAGE IN CASE HUMIDITY AND/OR TEMPERATURE AFFECTS THE FRAGMENTATION OF THE RUBBER) AND THE HANDLING OF THE PRODUCT HAD A ROLE IN THE REPORTED INCIDENT. NEEDLES WITH SHORT BEVELS (SUCH AS THIS PRODUCT) SHOULD PENETRATE THE STOPPER AT A NINETY-DEGREE ANGLE TO MINIMIZE THE RISK OF CORING. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD® BLUNT FILL NEEDLE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCREASED INCIDENTS OF ASPIRATION FROM THE MEDICATION: PUNCTURED RUBBER OF THE AMPOULE IS ASPIRATED AS WELL. THE COMPLAINT WILL NOW BE FILED. THE LOT NO. WILL BE KNOWN. I WILL ADD THE MAIL WITH THE DETAILS HERE.

    Description of Event or Problem · 0

    21/11/2023 - ADDITIONAL INFORMATION. COULD YOU PLEASE DESCRIBE THE EXACT PROCEDURE FOR USING THE NEEDLE? THE NEEDLE IS PLACED ON THE SYRINGE FILLED WITH NACL, THEN PUSHED THROUGH THE STOPPER OF THE AMPOULE WITHOUT RESISTANCE, A VISIBLE PLASTIC PARTICLE IS PUNCHED OUT AND FLOATS IN THE SOLUTION. HAVE YOU POSSIBLY ASPIRATED PARTICLES IN THE SYRINGE - WHICH ONES? THE PLASTIC PARTICLE CAN BE ASPIRATED WITH THE SYRINGE. DID YOU FEEL ANY RESISTANCE WHEN ASPIRATING? NO RESISTANCE DURING ASPIRATION 02/10/2023 - ADDITIONAL INFORMATION. COULD YOU PLEASE DESCRIBE THE EXACT PROCEDURE FOR USING THE NEEDLE? ATTACH MINISPIKE TO 100 ML NACL WITH 2 ML SYRINGE, ATTACH BD CANNULA TO REMIFENTANIL AMPOULE THEN INJECT NACL INTO SYRINGE OF 2 TO DISSOLVE THE MEDICATION IN THE AMPOULE. THEN DRAW LIQUID BACK INTO SYRINGE (CANNULA IS THEN DISCARDED) AND INJECT DRUG BACK INTO NACL INFUSION VIA MINISPIKE. DID YOU POSSIBLY ASPIRATE PARTICLES IN THE SYRINGE - WHICH ONES? IF PARTICLES WERE VISIBLE, AMPOULES WERE DISCARDED. ACCORDING TO THE PICTURE, RUBBER PIECES OF REMIFENTANIL WERE "PUNCHED OUT" BY RED CANNULA. SEE PHOTO. DID YOU FEEL ANY RESISTANCE DURING ASPIRATION? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269471 BD® BLUNT FILL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 230204 00382903031290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown