BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT 5ML SYRINGE

    MDR report key: 11143690 · Received January 9, 2021

    Report

    Report Number
    3002682307-2021-00005
    Event Type
    Malfunction
    Date Received
    January 9, 2021
    Date of Event
    December 11, 2020
    Report Date
    March 19, 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 EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-01-05. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1902101. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS INCIDENT, A SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, LEAKAGE WAS OBSERVED THROUGH THE PLUNGER ROD. THROUGH MAGNIFIED INSPECTION, DAMAGE WAS IDENTIFIED ON THE PLUNGER ROD. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED FROM DAMAGE TO THE PLUNGER LIP COMPONENT SPECIFICALLY. THIS TYPE OF DAMAGE CAN OCCUR DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR WITHIN THE ASSEMBLY MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT¿ 5ML SYRINGE MEDICATION LEAKED PAST STOPPER. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: SAMPLING PHYSIOLOGIC SERUM WITH THE SYRINGE, THE LIQUID LEAKS THROUGH THE PLUNGER. AS DESCRIBED IN THE EVENT IT WAS SALINE, THERE WAS NO EXPOSURE TO A HAZARDOUS PRODUCT. THE SYRINGE WAS REPLACED BY ANOTHER ONE, NO IMPACT ON PATIENT OR STAFF.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD DISCARDIT¿ 5ML SYRINGE MEDICATION LEAKED PAST STOPPER. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: SAMPLING PHYSIOLOGIC SERUM WITH THE SYRINGE, THE LIQUID LEAKS THROUGH THE PLUNGER. AS DESCRIBED IN THE EVENT IT WAS SALINE, THERE WAS NO EXPOSURE TO A HAZARDOUS PRODUCT. THE SYRINGE WAS REPLACED BY ANOTHER ONE, NO IMPACT ON PATIENT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40381 BD DISCARDIT 5ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1902101

    Patients

    Seq Age Sex Outcome Treatment
    1