BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE 18G X 1.5 IN.

    MDR report key: 6835703 · Received August 31, 2017

    Report

    Report Number
    3002682307-2017-00030
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    August 10, 2017
    Report Date
    January 16, 2018
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SECOND LOT NUMBER WAS OMITTED FROM THE INITIAL REPORT. THE INFORMATION FOR THIS LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 170412. MEDICAL DEVICE EXPIRATION DATE: 03/31/2022. DEVICE MANUFACTURE DATE: 04/18/2017.

    Additional Manufacturer Narrative · 1

    " INVESTIGATION: PICTURE AND RETURNED SAMPLE CONFIRMED THE DEFECT: ELONGATED RED PARTICLE INSIDE GLASS SYRINGE WHICH LOOKS LIKE RUBBER FRAGMENT (ALTHOUGH NO EVIDENCE OF WHICH VIAL WAS USED). WE HAVE BEEN PROVIDED WITH 1800 REFERENCE SAMPLES OF BATCH 170412 AND 12000 REFERENCE SAMPLES OF BATCH 170415. SOME SAMPLES WERE TESTED (USING DIFFERENT ANGLES OF PENETRATION) USING LAB VIALS WITH NO DIFFICULTIES AND ONE SMALL ROUND PARTICLE FROM VIALS STOPPER FRAGMENTATION WAS FOUND OF LOT 170412. ROOT CAUSE: "WE WERE ABLE TO DUPLICATE YOUR FAILURE MODE (ONE SMALL ROUND PARTICLE INSTEAD OF A ELONGATED) IN ONE REFERENCE SAMPLE, IN ACCORDANCE RESULTS ARE WITHIN SPECIFICATIONS. ON THE ONE HAND, BASED ON AVAILABLE INFORMATION, 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. ON THE OTHER HAND, 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. " CONCLUSION: COMPLAINT TRENDING REVIEW OF BOTH LOTS FOR THIS ISSUE REVEALS 1 COMPLAINT (INCLUDING THIS ONE) FOR EACH LOT. "*170412: OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEEDLES WERE PACKED IN MACHINE 2104 (APRIL 19-21ST 2017) AND HAD 67 VISUAL INSPECTIONS OF 100 UNITS EACH PERFORMED WITH ZERO DEFECTS NOTED. *170415: OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEEDLES WERE PACKED IN MACHINE 2104 (APRIL 22-24TH, 2017) WITH ZERO DEFECTS NOTED DURING IN-PROCESS VISUAL INSPECTIONS PERFORMED. ASSEMBLED NEEDLES ARE SHARED WITH BOTH PACKED BATCHES: #7089431 AND #7100455, WHICH WERE ASSEMBLED IN MACHINE Nº4408 (APRIL 3-7TH 2017 AND APRIL 18-23RD, 2017) WHICH HAD 212 AND 231 VISUAL INSPECTIONS OF 25 UNITS PERFORMED WITH ZERO DEFECTS NOTED, RESPECTIVELY. 1 QN (#9551) RELATED TO COLOR HUB DISPERSION WAS REACHED BUT THIS WOULD NOT AFFECT WHETHER OR NOT THE CORING EFECT ISSUE. CANNULA BATCHES:6270141 AND 8607895." CUSTOMER COMPLAINT IS RELATED TO CORING EFFECT WHICH IS CONFIRMED AFTER RECEIVED PICTURE OF SAMPLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN INDICATION OF FOREIGN MATTER IN THE BD¿ BLUNT FILL NEEDLE 18G X 1.5 IN. WHEN DRAWING MEDICATION FROM THE VIAL. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616171 BD¿ BLUNT FILL NEEDLE 18G X 1.5 IN. HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other