BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 30ML SLIP TIP SYRINGE

    MDR report key: 8852532 · Received August 1, 2019

    Report

    Report Number
    1911916-2019-00763
    Event Type
    Malfunction
    Date Received
    August 1, 2019
    Date of Event
    July 13, 2019
    Report Date
    August 16, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028338
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: FIVE (5) SAMPLES AND ONE (1) PHOTO WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE RETURNED SAMPLES WERE VISUALLY EXAMINED USING UNAIDED VISION. ALL FIVE (5) SAMPLES HAVE A FLANGE BROKEN OFF ON ONE (1) SIDE. ADDITIONALLY, ALL FIVE (5) SAMPLES SHOWS SIMILAR CRACKS NEAR WHERE THE FLANGE BROKE OFF INDICATING THAT ALL THE BARRELS WERE SUBJECTED TO A SIMILAR FORCE. THE PHOTO SHOWS THREE (3) SYRINGES WHICH HAVE PART OF ONE (1) FLANGE BROKEN OFF. THE DHR REVIEW ON BATCH 8107603 REVEALED A COMMENT THAT STATED THAT A KEYWAY ON THE IONIZER DIAL HAD BECOME WORN WHICH CAUSED EXCESSIVE MOVEMENT OF THE DIALS WHICH LED TO BARRELS JAMMING IN THE DIALS ON THE IONIZER STATION. THIS ISSUE COULD HAVE CAUSED OCCASIONAL DAMAGE TO THE BARRELS WHICH WAS NOT DETECTED DURING THE IN PROCESS INSPECTIONS. THE DHR REVIEW ON BATCH 8082819 DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED; HOWEVER, AS THIS BATCH WAS PRODUCED BEFORE BATCH 8107603 IT IS POSSIBLE THAT THE CONDITION REPORTED IN THE BATCH 8107603 ALREADY EXISTED AND WAS NOT NOTICED BY PRODUCTION ASSOCIATES. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ 30ML SLIP TIP SYRINGE PLUNGER ROD BROKE. THIS OCCURRED ON 20 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 20 SYRINGES WERE NOTICED WITH THE END OF PLUNGER ROD BROKEN DURING PRIMING. NO INJURY ON THE END USER.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8107603, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2018-04-17. MEDICAL DEVICE LOT #: 8082819, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2018-03-23. DEVICE EVALUATED BY MFR: 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 BD¿ 30ML SLIP TIP SYRINGE PLUNGER ROD BROKE. THIS OCCURRED ON 20 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 20 SYRINGES WERE NOTICED WITH THE END OF PLUNGER ROD BROKEN DURING PRIMING. NO INJURY ON THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646519 BD 30ML SLIP TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10 30382903028338

    Patients

    Seq Age Sex Outcome Treatment
    1 Other