BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBERCULIN SYRINGE

    MDR report key: 12465152 · Received September 13, 2021

    Report

    Report Number
    8041187-2021-00833
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    August 17, 2021
    Report Date
    September 17, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED/CORRECTED: D.4. MEDICAL DEVICE LOT #: 0233339. D.4. DEVICE EXPIRATION DATE: 2025-08-31. H.4. DEVICE MANUFACTURE DATE: 2020-08-20. H.6. IMDRF ANNEX B CODE: B01, B11, B14. H.6. IMDRF ANNEX C CODE: C1605. H.6. IMDRF ANNEX D CODE: D03. H.6. IMDRF ANNEX G CODE: G04127. H.6 INVESTIGATION SUMMARY: TWO PHOTOS AND ONE SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTOS AND THE SAMPLE, MISSING SYRINGE PARTS WERE OBSERVED INSIDE THE SEALED UNIT BLISTER PACKAGE. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE TEAM CARRIED OUT A SIMULATION AND CONFIRMED THAT THE CHECK WEIGHER IS ABLE TO BE AUTO-REJECTED THE SHELF CARTON WHEN THERE ARE ANY PARTS WITH A MISSING SYRINGE, THIS IS CHALLENGED AT THE START OF EVERY SHIFT. THE POSSIBLE ROOT CAUSE OF THE EMPTY PACKAGE COULD BE AT THE PRIMARY PACKAGING. DURING THE CHANGEOVER OF THE BOTTOM WEB OR THE TOP WEB, THERE WERE NO PARTS INSIDE THE UNIT BLISTER, AND THE SECONDARY PRODUCTION TECHNICIAN FAILED TO REMOVE THE EMPTY BLISTERS. THE NONCONFORMANCE COULD HAVE BEEN ESCAPEES RESULTING IT TO FLOW TO THE SECONDARY PACKAGING MACHINE. THE ON-THE-JOB TRAINING HAS BEEN REVIEWED AND RETRAINED AND STEPS TO HAVE THE PRODUCTION TECHNICIAN REMOVE ALL THE PARTS FROM THE CASE CARTON AND CHECK AND REMOVE ALL THE EMPTY POCKETS FROM THE CASE CARTON. THIS WAS COMPLETED BEFORE THE ACTION WAS TAKEN. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H.6 INVESTIGATION CONCLUSION: THE TEAM HAS REVIEWED SYRINGE MANUFACTURING PROCESS AND THE CHECK WEIGHER AT SECONDARY PACKAGING MACHINE HAD BEEN CHALLENGED. THE TEAM HAVE CARRIED OUT SIMULATION AND CONFIRMED THAT THE CHECK WEIGHER IS ABLE TO AUTO-REJECT THE SHELF CARTON WHEN THERE ARE ANY PARTS WITH MISSING SYRINGE. THIS IS CHALLENGED AT THE START OF EVERY SHIFT. THE POSSIBLE ROOT CAUSE COULD BE AT PRIMARY PACKAGING. DURING THE CHANGEOVER BOTTOM WEB OR TOP WEB, THERE WAS NO PARTS INSIDE UNIT BLISTER, AND SECONDARY PRODUCTION TECHNICIAN FAILED TO REMOVE THE EMPTY BLISTERS. THE NONCONFORMANCE COULD HAVE BEEN ESCAPEES RESULTING IT TO FLOW TO SECONDARY PACKAGING MACHINE. ACTION HAD BEEN TAKEN TO RETRAIN OJT-43212 TO ADD THE STEPS ¿PRODUCTION TECHNICIAN HAS TO REMOVE ALL THE PARTS FROM CASE CARTON AND CHECK.¿ AND ¿REMOVE ALL THE EMPTY POCKETS FROM THE CASE CARTON¿ ON 15 MAR 2021. THE COMPLAINT BATCH IS PRODUCED BEFORE ACTION TAKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ TUBERCULIN SYRINGE HAD FOREIGN MATTER IN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THE CUSTOMER USES THIS PRODUCT FOR COVID-19 VACCINATION. THE CUSTOMER REPORTED THE FOLLOWING ISSUES OF SYRINGE (302100): (1) FM: A LOT OF BLACK FMS WERE FOUND INSIDE THE BARREL.".

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ TUBERCULIN SYRINGE HAD FOREIGN MATTER IN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE CUSTOMER USES THIS PRODUCT FOR COVID-19 VACCINATION. THE CUSTOMER REPORTED THE FOLLOWING ISSUES OF SYRINGE (302100): (1) FM: A LOT OF BLACK FMS WERE FOUND INSIDE THE BARREL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362315 BD TUBERCULIN SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 0233339

    Patients

    Seq Age Sex Outcome Treatment
    1