BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 8569496 · Received May 1, 2019

    Report

    Report Number
    3002682307-2019-00283
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    April 11, 2019
    Report Date
    June 7, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    GAA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS BEEN PROVIDED WITH PHOTOS AND SAMPLES FOR CATALOG 303129, LOTS 190105, 1901107 AND 190109 TO INVESTIGATE FOR THIS RECORD. 5 REFERENCE SAMPLES, 2 USED ASSEMBLED SYRINGE AND ONE EMPTY VIAL. THE 2 USED SYRINGES SHOW A RED LONG PARTICLE STACKED ON THE INTERNAL WALL WHICH LOOKS LIKE A VIAL FRAGMENT. THE RETURNED NEEDLES WERE EXAMINED UNDER MICROSCOPE WITHOUT OBSERVING ANY DAMAGED CANNULA POINT AND WERE WELL-DEBURRED. SAMPLE WERE TESTED USING RETURNED LAB VIAL WITH NO DIFFICULTIES AND NO PARTICLES OR FRAGMENTS FROM THE VIAL STOPPER WERE FOUND. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. AFTER A DEVICE HISTORY REVIEW WAS COMPLETED AND NO ISSUES AND ABNORMALITIES DURING THE MANUFACTURING PROCESS RELATED TO THE CORING EFFECT WAS IDENTIFIED, THIS REPORTED ISSUE IS UNLIKELY TO BE CAUSE BY POOR OR INSUFFICIENT DE-BURRING PROCESS OF THE CANNULA. THE STOPPER CONDITIONS AND THE HANDLING CANNOT BE EXCLUDED TO PLAY A ROLE WHICH COULD HAVE SOME POTENTIAL IMPLICATION IN THE CORING EFFECT ISSUES AS WELL. NOT POSSIBLE TO DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RUBBER PARTICLES SIMILAR IN COLOR TO THE BD¿ BLUNT FILL NEEDLES' SEPTUM'S WERE SEEN INSIDE THE RADIOACTIVE ASPIRATION SYRINGES DURING USE. LOT #'S 190105, 190107, AND 190109 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE USE THESE NEEDLES WHEN PREPARING RADIOACTIVE SYRINGES. WHEN USED, YOU SOMETIMES SEE PLASTIC 'CURLS' IN THE ASPIRATION SYRINGE, WHICH MAINLY COME FROM THE NECK (HUB) ON THE NEEDLE (THE COLOR IS EQUAL).' I THINK THE MEAN THAT RUBBER PARTICLES ARE FOUND IN SYRINGE AFTER ASPIRATION, MAYBE COMING FROM CORING THE SEPTUM, AND THAT THE COLOR OF THE PARTICLES IS THE SAME AS THE ONE OF THE SEPTUM."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 190105, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2019-01-08. MEDICAL DEVICE LOT #: 190107, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2019-01-08. MEDICAL DEVICE LOT #: 190109, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2019-01-08. (B)(6). 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 · 1

    IT WAS REPORTED THAT RUBBER PARTICLES SIMILAR IN COLOR TO THE BD¿ BLUNT FILL NEEDLES' SEPTUM'S WERE SEEN INSIDE THE RADIOACTIVE ASPIRATION SYRINGES DURING USE. LOT #'S 190105, 190107, AND 190109 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE USE THESE NEEDLES WHEN PREPARING RADIOACTIVE SYRINGES. WHEN USED, YOU SOMETIMES SEE PLASTIC 'CURLS' IN THE ASPIRATION SYRINGE, WHICH MAINLY COME FROM THE NECK (HUB) ON THE NEEDLE (THE COLOR IS EQUAL)' I THINK THE MEAN THAT RUBBER PARTICLES ARE FOUND IN SYRINGE AFTER ASPIRATION, MAYBE COMING FROM CORING THE SEPTUM, AND THAT THE COLOR OF THE PARTICLES IS THE SAME AS THE ONE OF THE SEPTUM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361003 BD¿ BLUNT FILL NEEDLE SYRINGE AND NEEDLE GAA BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other