BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 ML BD LUER-LOK TIP SYRINGE

    MDR report key: 12475546 · Received September 15, 2021

    Report

    Report Number
    1911916-2021-00988
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 13, 2021
    Report Date
    September 15, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 9/14/2021 H.6. INVESTIGATION: IT WAS REPORTED THERE WAS LEAKING PAST THE STOPPER ON THREE OUT OF FOUR SYRINGES IN PREP. TO AID IN THE INVESTIGATION, FOUR SAMPLES AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THREE OF THE FOUR SAMPLES CAME IN A SEALED PLASTIC BAG WITH 25ML OF A RED SOLUTION. BASED ON THE COMPLAINT AND SOURCE OF THE COMPLAINT, THIS DRUG IS CHEMO. A VISUAL INSPECTION WAS PERFORMED THROUGH THE PLASTIC BAG. NO DROPLET OF RED SOLUTION WAS OBSERVED PAST THE STOPPER, OR BETWEEN THE STOPPER RIBS. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. FOR SAFETY REASONS, NO ADDITIONAL TESTING WAS COMPLETED ON THESE THREE SAMPLES. THE FOURTH SAMPLE WAS RECEIVED IN A SEALED PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED WITH A 10A MAGNIFIER LENS AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. A LEAK TEST WAS PERFORMED AND THE SAMPLE PASSED. THE PHOTO PROVIDED SHOWS THE THREE SAMPLES RECEIVED WITH THE RED SOLUTION. FROM THE PHOTO, IT IS NOT POSSIBLE TO OBSERVE THE SOLUTION PAST THE RUBBER STOPPER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT NUMBER 1091323. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE 30 ML BD LUER-LOK¿ TIP SYRINGES EXPERIENCED LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EPIRUBICIN LEAKING PAST STOPPER ON 3 OUT OF 4 SYRINGES IN PREP. I AM REPORTING ANOTHER SET OF 30 ML BD SYRINGES THAT ARE LEAKING. LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE

    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 THREE 30 ML BD LUER-LOK¿ TIP SYRINGES EXPERIENCED LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EPIRUBICIN LEAKING PAST STOPPER ON 3 OUT OF 4 SYRINGES IN PREP. I AM REPORTING ANOTHER SET OF 30 ML BD SYRINGES THAT ARE LEAKING. LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372629 30 ML BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302832 1091323 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1