BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 9914279 · Received April 1, 2020

    Report

    Report Number
    1213809-2020-00229
    Event Type
    Malfunction
    Date Received
    April 1, 2020
    Date of Event
    March 10, 2020
    Report Date
    May 20, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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: 3/24/2020. H.6. INVESTIGATION: SAMPLES AND PHOTOS RECEIVED FOR INVESTIGATION. SAMPLES WERE EVALUATED FOR BARREL, PLUNGER, AND/OR STOPPER DEFECTS AFFECTING THE FUNCTIONALITY OF THE PRODUCT. UPON OBSERVATION, THE SAMPLES PRESENT BARREL AND PLUNGER DAMAGE. THE LOT WAS INSPECTED ACCORDING TO THE CURRENT WORK INSTRUCTION WITH SATISFACTORY RESULTS FOR THE CHARACTERISTICS REQUIRED FOR ITS APPROVAL INCLUDING FUNCTIONAL TESTS. NO NON-CONFORMING PART THAT COULD BE ATTRIBUTABLE TO THE DEFECT REPORTED BY THE CLIENT WAS PRESENTED. NO DEVIATIONS (QUALITY NOTIFICATIONS) WERE REPORTED DURING THE MANUFACTURING PROCESS. IN ADDITION, THE NUMBER OF DEFECTIVE PARTS REPORTED IS WITHIN THE ACCEPTANCE QUALITY LEVEL (AQL). PROBABLE ROOT CAUSE, DURING THE TRANSFER OF THE SYRINGE FROM THE MAIN GUIDE TO THE DISC, FRACTURES IN THE SYRINGE MAY OCCUR. IMPROVEMENT ACTIONS WERE CONCLUDED IN THE LINE FOR SIMILAR DEFECTS PREVIOUSLY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 3ML LL 200 S/C MOLDING WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT BARRELS ON 2 SYRINGES ARE DEFECTED. DESCRIPTION: THIS IS FOR BERKELEY ADVANCED BIOMATERIALS' PURCHASE ORDER # 021020-6, AND THE SHIPMENT WAS RECEIVED ON FEBRUARY 10, 2020. IT LOOKS LIKE THE PLASTIC IN THE BARREL IS MELTED, AND THE PLUNGER CANNOT BE RETRACTED FROM THE BARREL LOWER THAN THE DEFECT IN THE BARREL. I WILL FOLLOW UP TOMORROW MORNING WITH MORE INFORMATION. PLEASE LET ME KNOW IF FISHER SCIENTIFIC WOULD LIKE BERKELEY ADVANCED BIOMATERIALS TO RETURN THE SYRINGES TO FISHER SCIENTIFIC OR SCRAP THE 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 3ML LL 200 S/C MOLDING WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT BARRELS ON 2 SYRINGES ARE DEFECTED. DESCRIPTION: THIS IS FOR BERKELEY ADVANCED BIOMATERIALS' PURCHASE ORDER # (B)(4), AND THE SHIPMENT WAS RECEIVED ON FEBRUARY 10, 2020. IT LOOKS LIKE THE PLASTIC IN THE BARREL IS MELTED, AND THE PLUNGER CANNOT BE RETRACTED FROM THE BARREL LOWER THAN THE DEFECT IN THE BARREL. I WILL FOLLOW UP TOMORROW MORNING WITH MORE INFORMATION. PLEASE LET ME KNOW IF FISHER SCIENTIFIC WOULD LIKE BERKELEY ADVANCED BIOMATERIALS TO RETURN THE SYRINGES TO FISHER SCIENTIFIC OR SCRAP THE SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373012 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 9048571 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other