BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE 60 ML

    MDR report key: 8900951 · Received August 16, 2019

    Report

    Report Number
    1911916-2019-00821
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    August 1, 2019
    Report Date
    August 28, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO (2) PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION, PHOTOS SHOW THAT THE THUMB PRESSES HAVE A PIECE BROKEN OFF. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. PLUNGER RODS ARE FED THROUGH A CHUTE TO THE ASSEMBLY PROCESS. IF THE CHUTE IS EMPTY, THE PLUNGER RODS CAN EXPERIENCE EXCESSIVE FORCE WHEN FALLING THROUGH THE ENTIRE CHUTE CAUSING DAMAGE TO THE RODS. ANOTHER POSSIBILITY IS THAT THE PLUNGER RODS WERE DAMAGED DURING THE INSERTION PROCESS INTO THE BARREL. A SENSOR WAS INSTALLED ON THE CHUTE TO DETERMINE IF THE CHUTE IS EMPTY. WHEN THE CHUTE IS FULL, THE PLUNGER RODS DO NOT SLIDE THE ENTIRE LENGTH OF THE CHUTE AND HAVE A REDUCED RISK OF DAMAGE. THE SENSOR WILL NOT ALLOW PLUNGER RODS TO AUTOMATICALLY FEED INTO THE CHUTE UNLESS IT IS FULL WHICH REDUCES THE RISK OF DAMAGE. BD ACKNOWLEDGES THAT THE RETURNED PHOTOS HAD PLUNGER RODS WHICH WERE DAMAGED WITH PIECES BROKEN OFF OF THE THUMB PRESS. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ LUER-LOK SYRINGE 60 ML PLUNGER BROKE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301035 BATCH NO. 7051533 AND 8023777 IT WAS REPORTED THE SYRINGE PLUNGER BROKE WHILE TAKING THE DILUENT. THE REASON OF THIS NOTIFICATION IS TO INFORM YOU ABOUT A QUALITY DEFECT, WHICH WAS REPORTED TO HAVE BROKEN THE SYRINGE PLUNGER. "DESCRIPTION OF DISCREPANCY: BREAKUP OF THE SYRINGE PLUNGER WHILE TAKING THE DILUENT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7051533, MEDICAL DEVICE EXPIRATION DATE: 2022-02-28, DEVICE MANUFACTURE DATE: 2017-02-20. MEDICAL DEVICE LOT #: 8023777, MEDICAL DEVICE EXPIRATION DATE: 2023-01-31, DEVICE MANUFACTURE DATE: 2018-01-23. 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¿ LUER-LOK SYRINGE 60 ML PLUNGER BROKE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301035, BATCH NO. 7051533 AND 8023777. IT WAS REPORTED THE SYRINGE PLUNGER BROKE WHILE TAKING THE DILUENT. THE REASON OF THIS NOTIFICATION IS TO INFORM YOU ABOUT A QUALITY DEFECT, WHICH WAS REPORTED TO HAVE BROKEN THE SYRINGE PLUNGER. "DESCRIPTION OF DISCREPANCY: BREAKUP OF THE SYRINGE PLUNGER WHILE TAKING THE DILUENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694457 BD LUER-LOK SYRINGE 60 ML PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other