BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 8179391 · Received December 19, 2018

    Report

    Report Number
    3002682307-2018-00325
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    November 12, 2018
    Report Date
    January 16, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    GAA
    UDI-DI
    00382903031290
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH 10 PACKED SAMPLES OF LOT 180905. COMPLAINT TRENDING REVIEW OF THIS LOT REVEALS NO MORE COMPLAINTS FOR THIS DEFECT. 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 2104 (SEPTEMBER 03-05TH, 2018) DURING WHICH 58 VISUAL INSPECTION OF 100 UNITS WERE PERFORMED WITH 0 DEFECTS NOTED. ASSEMBLED NEEDLES COMES FORM 3 BATCHES: #8242758: (AUGUST 31 ¿ SEPTEMBER 3RD, 2018) MACHINE 4408 DURING WHICH 171 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. #8246877: (SEPTEMBER 3-11ST, 2018) MACHINE 4408 DURING WHICH 275 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. #8239756: (AUGUST 27-30TH 2018) MACHINE 4408 DURING WHICH 124 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. CANNULA BATCH #8235921. INVESTIGATION CONCLUSION: RETURNED NEEDLES WERE EXAMINED UNDER MICROSCOPE WITHOUT OBSERVING ANY DAMAGED CANNULA POINT AND WELL-DEBURRED. SAMPLES WERE TESTED (USING DIFFERENT ANGLES OF PENETRATION) USING A LAB VIAL WITH NO DIFFICULTIES AND NO PARTICLES FROM VIALS STOPPER FRAGMENTATION WERE FOUND. ROOT CAUSE DESCRIPTION: BASED ON SAMPLE EVALUATION RESULTS AND SINCE DHR SHOW NO EVIDENCE, ABNORMALITIES AND NO ISSUES DURING NEEDLES MANUFACTURING RELATED TO CORING EFFECT AND TAKING INTO ACCOUNT 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 SECURE 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. RATIONALE: SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT AND NO CONFIRMED COMPLAINT, NO ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INJECTION WITH BD¿ BLUNT FILL NEEDLES THE CUSTOMER NOTICE RUBBER PARTICLES COMING FROM THE VIAL STOPPER.

    Additional Manufacturer Narrative · 1

    (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 AFTER INJECTION WITH BD¿ BLUNT FILL NEEDLES THE CUSTOMER NOTICE RUBBER PARTICLES COMING FROM THE VIAL STOPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017356 BD¿ BLUNT FILL NEEDLE NEEDLE GAA BECTON DICKINSON, S.A. 180905 00382903031290

    Patients

    Seq Age Sex Outcome Treatment
    1 Other