BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD

    MDR report key: 8397206 · Received March 6, 2019

    Report

    Report Number
    3002682307-2019-00182
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    February 18, 2019
    Report Date
    March 14, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. NEEDLES WERE PACKED IN MACHINE 2101 (SEPTEMBER 06-08TH, 2018) DURING WHICH 66 VISUAL INSPECTION OF 100 UNITS WERE PERFORMED WITH 0 DEFECTS NOTED. NEEDLES WERE ASSEMBLED IN MACHINE 4407 AND COME FROM TWO BATCHES: -#8246877: (SEPTEMBER 3-11ST, 2018) DURING WHICH 264 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. -#8242758. (AUGUST 31 ¿ SEPTEMBER 3RD, 2018) DURING WHICH 171 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. CANNULA BATCH #8235921. BD HAS BEEN PROVIDED WITH 4 PACKED SAMPLES OF LOT 180908, ONE UNUSED VIAL AND 1 USED SYRINGE. USED SYRINGE SHOW A GREY PARTICLE STACKED ON INTERNAL WALL WHICH LOOKS LIKE A VIAL FRAGMENT. RETURNED NEEDLES WERE EXAMINED UNDER MICROSCOPE WITHOUT OBSERVING ANY DAMAGED CANNULA POINT AND WELL-DEBURRED. SAMPLES WERE TESTED (USING DIFFERENT ANGLES OF PENETRATION) USING RETURNED LAB VIAL WITH NO DIFFICULTIES AND NO PARTICLES FROM VIALS STOPPER FRAGMENTATION WERE FOUND. CONCLUSION(S): BASED ON SAMPLE EVALUATION RESULTS AND SINCE DHR SHOW NO EVIDENCE, ABNORMALITIES AND NO ISSUES DURING NEEDLES MANUFACTURING RELATED TO CORING EFFECT AND CONSIDERING THE PREVENTIVE MEASURES AND CONTROLS IN PLACE DURING THE CANNULA MANUFACTURING PROCESS, THE CORING EFFECT (RISK OF CATCHING INTERNAL WALL OF VIAL STOPPER) 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. NEVERTHELESS, THE STOPPER CONDITIONS AND THE HANDLING CANNOT BE EXCLUDED TO PLAY A ROLE WHICH COULD HAVE SOME POTENTIAL IMPLICATION IN THE CORING EFFECT ISSUES. NEEDLES BLUNT FILL NEEDLE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD HAD PIECES OF RUBBER IN THE SYRINGE. CUSTOMER SAID, ¿ANEASTHESIA NOTICES AFTER DRAWING OF THE MEDICINE ROCURONIUM (AMPILE WITH RUBBER STOPPER) CUTTINGS OF THE RUBBER IN THE SYRINGE. THIS OCCURED IN MANY OP WARDS IN DER ANEASTHESIA.¿ FOUND DURING USE. NO REPORTS OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). (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 BD¿ NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD HAD PIECES OF RUBBER IN THE SYRINGE. CUSTOMER SAID, ¿ANAESTHESIA NOTICES AFTER DRAWING OF THE MEDICINE ROCURONIUM (AMPILE WITH RUBBER STOPPER) CUTTINGS OF THE RUBBER IN THE SYRINGE. THIS OCCURED IN MANY OP WARDS IN DER ANAESTHESIA.¿ FOUND DURING USE. NO REPORTS OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186864 BD NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD SYRINGE FMF BECTON DICKINSON, S.A. 180908

    Patients

    Seq Age Sex Outcome Treatment
    1 Other