BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ SYRINGE

    MDR report key: 15234932 · Received August 16, 2022

    Report

    Report Number
    2243072-2022-01350
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    July 20, 2022
    Report Date
    August 22, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 28-JUL-2022. INVESTIGATION SUMMARY: THERE ARE 40 SAMPLES AND ONE VIDEO ALONG WITH THE REPORTED COMPLAINT OF WATER DROPLETS IN SYRINGE. THE INVESTIGATING TEAM HAS USED THE RETENTION SAMPLES OF MATERIAL NUMBER 302438 AND LOT NUMBER 2150646 FOR INVESTIGATING THE REPORTED DEFECT. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON TEN RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES FOR WATER DROPLETS IN SYRINGE AND NO WATER DROPLETS IN SYRINGE WAS FOUND IN THE TEN RETENTION SAMPLES. THE 40 SAMPLES WERE REVIEWED BY THE INVESTIGATION TEAM AND THE FOLLOWING OBSERVATIONS WERE MADE: 4. THERE WAS VISIBLE CONDENSATION OF WATER DROPLETS INSIDE THE FLUID PATH. 5. THE SAMPLES WERE OPENED AND TESTED FOR THE DROPLETS IN THE SYRINGE AND THE TESTS CONFIRMED THE PRESENCE OF WATER AS COMPLAINED BY THE CUSTOMER. 6. A RETENTION SAMPLE OF LOT NO 2150646 AND ANOTHER BATCH WERE USED FOR SIMULATIONS, THE CHECK FOR THE PRESENCE OF WATER SIMULATION CONCLUSION: 4. THE RETENTION SAMPLES DID NOT SHOW ANY CONDENSATION OF WATER INSIDE THE PRODUCT. 5. THE SIMULATION DONE ON THE RETENTION SAMPLES OF 2150646 SHOWED PENETRATIONS AND CONDENSATION OF WATER ON THEM WHEN PRODUCTS WERE WET AND THEN DRIED. 6. THE PRODUCT HAS GOT WET AND SUBSEQUENTLY DRIED DURING TRANSIT OF THE PRODUCT FROM THE PLANT TO CUSTOMER. THE PROBABLE ROOT CAUSE IS THE PRODUCT HAS GOT WET AND GOT DRIED, DUE TO WHICH THE BOX AND LABELS HAVE GOT DRIED BUT THE WATER CONDENSATION INSIDE THE SYRINGE WAS UNABLE TO DRY UP AS ITS SEALED AND PACKED. THE DEFECT HAS THEREFORE CAUSED DUE TO IMPROPER TRANSPORTATION OR STORAGE. THE DHR OF MATERIAL NO. 302438 WITH BATCH NO. 2150646 WAS CHECKED AND THERE WAS NO QUALITY NOTIFICATION FOUND ON THIS LOT NO. FROM ITS PRODUCTION DATE TO ITS DISPATCH ON DATE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 32 BD DISCARDIT¿ SYRINGES HAD WATER DROPLETS IN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WATER SUBSTANCE FOUND INSIDE THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 32 BD DISCARDIT¿ SYRINGES HAD WATER DROPLETS IN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WATER SUBSTANCE FOUND INSIDE THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950638 BD DISCARDIT¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 2150646

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown