BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE

    MDR report key: 11670704 · Received April 15, 2021

    Report

    Report Number
    3002682307-2021-00133
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 17, 2021
    Report Date
    May 3, 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

    CORRECTION: AN ADDITIONAL FAILURE MODE WAS FOUND VIA THE BD INVESTIGATION. THE FOLLOWING FIELD HAS BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 1 BD DISCARDIT¿ II SYRINGE FROM LOT 2010194, AND 1 SYRINGE FROM LOT 2011154 LEAKED PAST THE PISTON DURING USE. ADDITIONALLY, THE STOPPER WAS FOUND TO BE DAMAGED/DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "THE SYRINGE LEAKS AT THE LEVEL OF THE PISTON." VIA BD INVESTIGATION: "THROUGH EXAMINATION OF THE SAMPLES, LEAKAGE WAS OBSERVED THROUGH THE PLUNGER ROD. THROUGH MAGNIFIED INSPECTION, DAMAGE WAS OBSERVED TO THE PLUNGER LIP COMPONENTS." D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2021-04-09. INVESTIGATION: H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2010194. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE ORIGINALLY FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THE AFFECTED SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, LEAKAGE WAS OBSERVED THROUGH THE PLUNGER ROD. THROUGH MAGNIFIED INSPECTION, DAMAGE WAS OBSERVED TO THE PLUNGER LIP COMPONENTS. PLUNGER LIP DAMAGE CAN BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS 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 INITIATED WITH THE AIM OF REDUCING THIS TYPE OF DEFECT. 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 1 BD DISCARDIT¿ II SYRINGE FROM LOT 2010194, AND 1 SYRINGE FROM LOT 2011154 LEAKED PAST THE PISTON DURING USE. ADDITIONALLY, THE STOPPER WAS FOUND TO BE DAMAGED/DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "THE SYRINGE LEAKS AT THE LEVEL OF THE PISTON." VIA BD INVESTIGATION: "THROUGH EXAMINATION OF THE SAMPLES, LEAKAGE WAS OBSERVED THROUGH THE PLUNGER ROD. THROUGH MAGNIFIED INSPECTION, DAMAGE WAS OBSERVED TO THE PLUNGER LIP COMPONENTS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2010194. MEDICAL DEVICE EXPIRATION DATE: 2025-09-30. DEVICE MANUFACTURE DATE: 2020-10-19. MEDICAL DEVICE LOT #: 2011154. MEDICAL DEVICE EXPIRATION DATE: 2025-10-31. DEVICE MANUFACTURE DATE: 2020-10-29. 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 1 BD DISCARDIT¿ II SYRINGE FROM LOT 2010194, AND 1 SYRINGE FROM LOT 2011154 LEAKED PAST THE PISTON DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "THE SYRINGE LEAKS AT THE LEVEL OF THE PISTON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572495 BD DISCARDIT II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2010194

    Patients

    Seq Age Sex Outcome Treatment
    1