BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 14707480 · Received June 15, 2022

    Report

    Report Number
    3002682307-2022-00162
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    May 7, 2022
    Report Date
    July 15, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUTION: YES. D9: RETURNED TO MANUFACTURER ON: 29-JUN-2022 H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309110 AND LOT NUMBER 2202251. 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, PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, LEAKAGE WAS OBSERVED, CONFIRMING THE REPORTED DEFECT. IT HAS BEEN CONCLUDED THAT THE LEAKAGE MOST LIKELY RESULTED FROM DAMAGE TO THE PLUNGER LIP COMPONENT. THIS TYPE OF DAMAGE MAY BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR WITHIN THE PLUNGER ASSEMBLY MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II SYRINGE LEAKED WATER PAST THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "2-DAY-OLD INFANT MANAGED FOR SPONTANEOUS PREMATURITY AT 29 WEEKS OF AMENORRHOEA. THE NURSERY NURSE NOTES THAT THE WATER FOR INJECTION (WFI) TAKEN LEAKS FROM THE PLUNGER OF THE 10ML SYRINGE. THIS IS A RECURRING INCIDENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II SYRINGE LEAKED WATER PAST THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "2-DAY-OLD INFANT MANAGED FOR SPONTANEOUS PREMATURITY AT 29 WEEKS OF AMENORRHOEA. THE NURSERY NURSE NOTES THAT THE WATER FOR INJECTION (WFI) TAKEN LEAKS FROM THE PLUNGER OF THE 10ML SYRINGE. THIS IS A RECURRING INCIDENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313734 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2202251

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Unknown