BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ

    MDR report key: 10025826 · Received May 5, 2020

    Report

    Report Number
    1911916-2020-00433
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    April 8, 2020
    Report Date
    May 28, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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: 5/27/2020. H.6. INVESTIGATION: FOUR SAMPLES WERE RECEIVED. THEY CAME IN OPENED PACKAGING BLISTERS. THEY ALL ARE CONTAMINATED. ONE SAMPLE HAS A LABEL ¿PROPOFOL¿, THE OTHER THREE SAMPLES HAVE RESIDUES OF AN UNKNOWN DRUG. ALL FOUR HAVE RESIDUES OF THE DRUG BETWEEN THE STOPPER RIBS. ALL FOUR SAMPLES ARE 60ML. THIS PRODUCT WAS TRANSITIONED TO 50ML WHICH WILL MITIGATE THIS TYPE OF LEAKAGE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 60ML LL TIP 1ML 2 OZ IN 1/4 OZ EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MEDICINE WAS GOING TO PULLED INTO THE SYRINGE TO PUT INTO THE INFUSION-PUMP. WHEN THEY PULLED UP THE MEDICINE, THE MEDICINE WENT BEHIND THE SILICON/PLUNGER. THEY CHANGE TO ANOTHER SYRINGE AND THAT WORKS FINE. LOT-NUMBER 9120875 AND 9120915.

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9120875, MEDICAL DEVICE EXPIRATION DATE: 2024-04-30, DEVICE MANUFACTURE DATE: 2019-04-30, MEDICAL DEVICE LOT #: 9120915, MEDICAL DEVICE EXPIRATION DATE: 2024-04-30, DEVICE MANUFACTURE DATE: 2019-04-30.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 60ML LL TIP 1ML 2 OZ IN 1/4 OZ EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MEDICINE WAS GOING TO PULLED INTO THE SYRINGE TO PUT INTO THE INFUSION-PUMP. WHEN THEY PULLED UP THE MEDICINE, THE MEDICINE WENT BEHIND THE SILICON/PLUNGER. THEY CHANGE TO ANOTHER SYRINGE AND THAT WORKS FINE. LOT NUMBER 9120875 AND 9120915.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486727 SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H10 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 Other