BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE

    MDR report key: 8846393 · Received July 31, 2019

    Report

    Report Number
    3002682307-2019-00422
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 11, 2019
    Report Date
    August 28, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH SAMPLES FOR CATALOG 303129 LOTS 190514, 190510, 190608 AND 190408 TO INVESTIGATE FOR THIS RECORD. SAMPLES WERE TESTED USING A LAB VIAL WITH NO DIFFICULTIES AND NO PARTICLES FROM VIALS STOPPER FRAGMENTATION WERE FOUND IN ANY OF THE PROVIDED SAMPLES OF ALL BATCHES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE AS IT RELATES TO THE NEEDLE MANUFACTURING PROCESS. BD UNDERSTANDS A CORING EFFECT TOOK PLACE: RISK OF CATCHING INTERNAL WALL OF VIAL STOPPER. TAKING INTO ACCOUNT THE PREVENTIVE MEASURES AND CONTROLS IN PLACE DURING THE CANNULA MANUFACTURING PROCESS, THE CORING EFFECT IS UNLIKELY TO BE CAUSED BY POOR OR INSUFFICIENT DE-BURRING PROCESS OF THE CANNULA. IN ADDITION, AS A PART OF FRAGA CANNULA INCOMING INSPECTION, VISUAL EXAMINATION (INCLUDING CANNULA POINT CONDITIONS, FLASHES, CLEANLINESS, CLOGGED AND CRASHED CANNULA) MEASUREMENTS AND PENETRATION TEST ARE PERFORMED. THE STOPPER CONDITIONS AND THE HANDLING CANNOT BE EXCLUDED TO PLAY A ROLE WHICH COULD HAVE SOME POTENTIAL IMPLICATION IN THE CORING EFFECT ISSUES. BLUNT FILL NEEDLES ARE SPECIALLY DESIGNED WITH UNIQUE 40° BEVEL TO MINIMIZE CORING EFFECT AND 1.5¿ LONG, TO EASILY PENETRATE SINGLE AND DOUBLE SEPTUM BARRIERS (RUBBER STOPPERS AND IV BAG SEPTUM¿S). WHEN SECURING THE HUB OF NEEDLE TO SYRINGE, REMOVE NEEDLE SHIELD AND ENSURE THAT NEEDLE PUNCTURES STOPPER AT 90° TO MINIMIZE RISK OF CATCHING INTERNAL WALL OF VIAL STOPPER. AS THIS IS THE FIRST TIME EACH LOT IS REPORTED, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE CORING OCCURRED WITH A BD BLUNT FILL NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: THE RUBBER BEING PUNCHED OUT BY THE NEEDLE.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 190510. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-05-06. MEDICAL DEVICE LOT #: 190514. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-05-06. MEDICAL DEVICE LOT #: 1090403. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-03-27. MEDICAL DEVICE LOT #: 190408. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-03-27. MEDICAL DEVICE LOT #: 190608. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2019-06-04. " 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 DURING USE CORING OCCURRED WITH A BD BLUNT FILL NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE RUBBER BEING PUNCHED OUT BY THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640615 BD BLUNT FILL NEEDLE NEEDLE FMI BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other