BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 20 ML SYRINGE

    MDR report key: 11891514 · Received May 26, 2021

    Report

    Report Number
    3002682307-2021-00213
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 20, 2021
    Report Date
    July 20, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUATION? YES, D10: RETURNED TO MANUFACTURER ON: 2021-07-06. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2102187. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, LEAKAGE WAS OBSERVED AT THE PLUNGER ROD COMPONENT. THROUGH MAGNIFIED INSPECTION, IT WAS DETERMINED THAT THE LEAKAGE WAS A CONSEQUENCE OF DAMAGE TO THE PLUNGER LIP COMPONENT. TWENTY ADDITIONAL RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR EXAMINATION. THE RETAINED SAMPLES DID NOT REVEAL ANY SIGNS OF DEFECT. DAMAGE TO THE PLUNGER LIP COMPONENT MAY OCCUR DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING FACILITY OR WITHIN THE PLUNGER ASSEMBLY MACHINE. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. A QUALITY PROCESS HAS BEEN OPENED WITH THE AIM OF REDUCING THE RECURRENCE OF THIS TYPE OF DAMAGE. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II 20 ML SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POOR PLUNGER SEAL, PRODUCT LEAKAGE AND AIR INSERTION WHEN THE NURSE DREW NACL. THE SYRINGE WAS NOT USED, ANOTHER SYRINGE WAS USED.

    Additional Manufacturer Narrative · 1

    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 THE BD DISCARDIT¿ II 20 ML SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POOR PLUNGER SEAL, PRODUCT LEAKAGE AND AIR INSERTION WHEN THE NURSE DREW NACL. THE SYRINGE WAS NOT USED, ANOTHER SYRINGE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786738 BD DISCARDIT II 20 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2102187

    Patients

    Seq Age Sex Outcome Treatment
    1