BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCARDIT II¿ SYRINGE WITH NEEDLE

    MDR report key: 7514936 · Received May 15, 2018

    Report

    Report Number
    3002682307-2018-00114
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Date of Event
    April 20, 2018
    Report Date
    April 26, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION RESULTS: SUMMARY: THE COMPLAINT HISTORY REVIEW SHOWED THAT THIS KIND OF MIX UP HAD NOT BEEN REPORTED IN THE LAST FIVE YEARS. THE ROOT CAUSE ANALYSIS CONCLUDE THAT THE ISSUE WAS PRODUCED DUE TO A PUNCTUAL FAILURE IN THE LINE CLEARANCE WHEN ONE SINGLE NEEDLE REMAIN IN THE MACHINE, AND THE POSSIBILITY OF HAVING THIS ISSUE AGAIN IS PRACTICALLY NEGLIGIBLE. ACCORDING TO THE DESCRIBED CIRCUMSTANCES AND BASED ON ALL THE PREVENTIVE MEASURES AND OUR STRINGENT SAMPLING PROCEDURES, WE ARE CERTAIN THAT THIS HAS BEEN AN ISOLATED ISSUE AND ANY RECURRENCE IS NEGLIGIBLE. MOREOVER, THIS ISSUE IS GOING TO BE COMMUNICATED IN THE PRODUCTION AREA TO INCREASE THE ATTENTION LEVEL REGARDING THIS KIND OF THIS PROCESS. CONCLUSION: SAMPLE EVALUATION- WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLE AND ONE REFERENCE SAMPLE. ALSO PICTURES OF THE SAMPLES WERE RECEIVED. THE AFFECTED SAMPLE SHOWS A DIFFERENT NEEDLE COLOR (BLUE) REGARDING GAUGE 23 X 1¿ THAN THE USUAL ONE (BLACK) REGARDING GAUGE 22 X 1 ½¿, THE PACKAGE WAS CORRECTLY SEALED. WE COULD CONFIRM THE REPORTED ISSUE. BHR REVIEW: A BHR FOR THE ABOVE BATCH WAS CONDUCTED CONFIRMING THAT THE BATCH WAS RELEASED ACCORDING TO DEFINED PROCEDURES AND REQUIREMENTS. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. SYRINGES WERE PACKED IN MACHINE Nº2025 ((B)(6) 2017) DURING WHICH 16 VISUAL INSPECTIONS OF 100 UNITS EACH WERE CARRIED OUT WITH ZERO DEFECTS NOTED. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE NEEDLE LOT #7243144, WHICH WAS ASSEMBLED IN MACHINE Nº4410 ((B)(6) 2017) DURING WHICH 175 VISUAL INSPECTIONS OF 25 UNITS EACH WERE CARRIED OUT WITH ZERO DEFECTS NOTED. NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. THE LINE CLEARANCE PROCESS HAS BEEN ALSO REVIEWED. LINE CLEARANCE FOR LOT #1709170 WAS PERFORMED ON 13TH SEPTEMBER, 2017 AND REGISTERED IN FORMAT C-8813 AND C-8810. LINE CLEARANCE OF PRIMARY PACKAGING MACHINE Nº4613 AND SECONDARY MACHINE Nº2025 (PRODUCTION LINE 4) WAS COMPLETED AS EXPECTED. ROOT CAUSE: AFTER THE ANALYSIS OF THE BHR REVIEW, WE REALIZED THAT THE PREVIOUS LOT MANUFACTURED IN PRODUCTION LINE 4 (WHERE THE ISSUE WAS PRODUCED) WAS THIS: LOT: #1709505, PRODUCT: DII SYRINGE 2ML + G23 X 1¿ (B)(6); REF: (B)(4). THIS INFORMATION MATCHES WITH THE REPORTED ISSUE AND THE PROVIDED PICTURES. THE PREVIOUS MANUFACTURED LOT WAS PRODUCED WITH BLUE HUB NEEDLES OF G23 X 1¿, WHICH IS RELATED WITH THE MIX UP FOUND BY THE CUSTOMER. FOR THAT REASON WE CONCLUDE THAT THE MOST PROBABLY ROOT CAUSE OF THE REPORTED ISSUE IS THAT THE LINE CLEARANCE PERFORMED PRIOR TO THE REPORTED LOT WAS DONE CORRECTLY, BUT ONE NEEDLE OF G23 X 1¿ WITH BLUE HUB WAS NOT DETECTED BY THE OPERATOR, SO WAS NOT REMOVED FROM THE PRIMARY PACKAGING MACHINE. THEREFORE, THE PRESENCE OF THIS BLUE HUB NEEDLE IN THE PRIMARY PACKAGING MACHINE DURING THE PRODUCTION OF LOT #1709170, PRODUCED THE REPORTED MIX UP ISSUE. ACCORDING TO THE DESCRIBED CIRCUMSTANCES AND BASED ON ALL THE PREVENTIVE MEASURES AND OUR STRINGENT SAMPLING PROCEDURES, WE ARE CERTAIN THAT THIS HAS BEEN AN ISOLATED ISSUE AND ANY RECURRENCE IS NEGLIGIBLE. CONFIRMATION: THE RETURNED SAMPLES PRESENTED THE REPORTED ISSUE. WE COULD CONFIRM THE REPORTED ISSUE. CAPA DETERMINATION: NO - BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PACKAGING, THE BLISTER ON A 2ML DISCARDIT II¿ SYRINGE WITH NEEDLE WAS FOUND WITH A DIFFERENT TYPE OF NEEDLE. IT WAS REPORTED, THE CORRECT NEEDLE COLOR IS GRAY AND THE INCORRECT NEEDLE COLOR IS BLUE. IN ADDITION, THE BLUE NEEDLE HUB WAS ALSO SHORTER THAN THE CORRECT GRAY ONE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358430 DISCARDIT II¿ SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1709170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other