BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL EURO 125 S/C

    MDR report key: 11803333 · Received May 10, 2021

    Report

    Report Number
    1213809-2021-00302
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 12, 2021
    Report Date
    May 26, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096497
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO AND THREE LOOSE 5ML SYRINGES WITH BLISTER PACKS FROM BATCH 0213256 (P/N 309649) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED ALL THREE OF THE SYRINGES EACH HAD SINGLE LENGTHWISE CRACK IN THE BARREL WALL EXTENDING FROM APPROXIMATELY THE 1ML TO 4ML MARKING. POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 5ML LL EURO 125 S/C WAS DAMAGED. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 L.L. 5ML SYRINGES WITH CRACKS. THE DEVICES WERE NOT IN CONTACT WITH A TOXIC SUBSTANCE. CIRCUMSTANCES / DESCRIPTION: WHEN COLLECTING PPI WATER TO REPLENISH VIDAZA VIALS: OBSERVATION OF 3 SYRINGES WITH CRACKED BODIES. NO CLINICAL CONSEQUENCES FOR PATIENT OR OPERATOR. PRECAUTIONARY MEASURES AND ACTIONS TAKEN: QUARANTINE OF CRACKED SYRINGES, USE OF NEW 5ML SYRINGES.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 5ML LL EURO 125 S/C WAS DAMAGED. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 L.L. 5ML SYRINGES WITH CRACKS. THE DEVICES WERE NOT IN CONTACT WITH A TOXIC SUBSTANCE. CIRCUMSTANCES / DESCRIPTION: WHEN COLLECTING PPI WATER TO REPLENISH VIDAZA VIALS: OBSERVATION OF 3 SYRINGES WITH CRACKED BODIES. NO CLINICAL CONSEQUENCES FOR PATIENT OR OPERATOR. PRECAUTIONARY MEASURES AND ACTIONS TAKEN: QUARANTINE OF CRACKED SYRINGES, USE OF NEW 5ML SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694953 SYRINGE 5ML LL EURO 125 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0213256 00382903096497

    Patients

    Seq Age Sex Outcome Treatment
    1