BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL BNS

    MDR report key: 11404758 · Received March 3, 2021

    Report

    Report Number
    1213809-2021-00113
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    December 23, 2020
    Report Date
    April 7, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: 2/15/2021. H.6. INVESTIGATION: EIGHTEEN PHOTOS AND TWENTY-ONE LOOSE 3ML SYRINGES WERE RECEIVED AND EVALUATED. THE SYRINGES WERE SEPARATED ACCORDINGLY: TWO BAGS CONTAINING A TOTAL OF FIVE SYRINGES LABELED WITH BATCH 9178295. TWO SYRINGES HAD EMBEDDED FOREIGN MATTER PARTICLES. ONE SYRINGE HAD MULTIPLE SMALL BLACK PARTICLES UNDER THE FLANGE THAT APPEARED TO BE BURNT PLASTIC. ONE SYRINGE HAD TWO SMALL WHITE EMBEDDED PARTICLES. THE COMPOSITION OF THE WHITE PARTICLES COULD NOT BE DETERMINED BUT WERE LARGE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. . THREE SYRINGE HAD MINOR SURFACE SCRATCHES THAT DID NOT AFFECT THE FORM FIT OR FUNCTION OF THE DEVICE, WHICH WERE ACCEPTABLE PER PRODUCT SPECIFICATION. FOUR BAGS CONTAINING A TOTAL OF SIXTEEN SYRINGES LABELED WITH BATCH 9256946. ONE SYRINGE HAD A SMALL BLACK FOREIGN MATTER FIBER OUTSIDE THE FLUID PATH. THE FIBER APPEARED TO BE A BUILDUP OF STOPPER SHAVINGS FROM THE BACK RIB WITH A STRAND STILL ATTACHED. THE FIBER WAS LARGE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. SIX OF THE SYRINGES HAD BLACK EMBEDDED FOREIGN MATTER PARTICLES IN VARIOUS LOCATIONS INCLUDING THE MIDDLE OF THE BARREL, TIP, AND FLANGE. THE PARTICLES APPEARED TO BE BURNT PLASTIC WITH FIVE OF THE SYRINGES HAVING A LARGE PARTICLE , WHICH WERE REJECTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE HAD A PORTION OF THE LOGO FADED WITH MOST OF THE "B" MISSING, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. EIGHT SYRINGES HAD SCRATCHES IN THE BARREL AND COLLAR. SEVEN WERE COSMETIC IN NATURE WITH NO EFFECT TO THE FORM FIT OR FUNCTION OF THE DEVICE. ONE SYRINGE HAD A PORTION OF ONE OF THE GRAD LINES MISSING MORE THAN 50% WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. PER PROCEDURE, AFTER START UP, ALL MOLDED PARTS ARE SCRAPPED UNTIL NO DEGRADED PLASTIC IS OBSERVED. IF THIS IS NOT PERFORMED THOROUGHLY A PIECE WITH THIS CONDITION CAN GET THROUGH. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. POTENTIAL ROOT CAUSE FOR THE SCRATCHED BARREL AND DAMAGED STOPPER DEFECTS ARE ASSOCIATED WITH THE ASSEMBLY PROCESS. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. DHR'S WERE REVIEWED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 SYRINGE 3ML LL BNS HAD FOREIGN MATTER (9) OR SCALE MARKING ISSUES (1) DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THERE WAS DIRT, FOREIGN OBJECTS, SCRATCHED, MISSING AND FADED PRINTING ON THE SYRINGES. PER EMAIL: I NEED YOUR HELP WITH BD PART NUMBER 301073, LOT NUMBERS 9256946 AND 9254057 (QOSINA PART NUMBER C3303). OUR CUSTOMER HAS REPORTED FINDING DIRT, FOREIGN OBJECTS, SCRATCHED, MISSING AND FADED PRINTING THEY ARE REQUIRING A FORMAL INVESTIGATION AND ROOT CAUSE / CORRECTIVE ACTION REPORT AND A CREDIT. TOTAL PARTS REJECTED ARE 21. PLEASE ADVISE. THANK YOU FOR YOUR HELP."

    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 #: 9256946, MEDICAL DEVICE EXPIRATION DATE: 2024-08-30, DEVICE MANUFACTURE DATE: 2019-09-13; MEDICAL DEVICE LOT #: 9178295, MEDICAL DEVICE EXPIRATION DATE: 2024-06-30, DEVICE MANUFACTURE DATE: 2019-06-27. 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 10 SYRINGE 3ML LL BNS HAD FOREIGN MATTER (9) OR SCALE MARKING ISSUES (1) DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THERE WAS DIRT, FOREIGN OBJECTS, SCRATCHED, MISSING AND FADED PRINTING ON THE SYRINGES. PER EMAIL: I NEED YOUR HELP WITH BD PART NUMBER 301073, LOT NUMBERS 9256946 AND 9254057 (QOSINA PART NUMBER C3303). OUR CUSTOMER HAS REPORTED FINDING DIRT, FOREIGN OBJECTS, SCRATCHED, MISSING AND FADED PRINTING. THEY ARE REQUIRING A FORMAL INVESTIGATION AND ROOT CAUSE / CORRECTIVE ACTION REPORT AND A CREDIT. TOTAL PARTS REJECTED ARE 21. PLEASE ADVISE. THANK YOU FOR YOUR HELP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303715 SYRINGE 3ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9178295

    Patients

    Seq Age Sex Outcome Treatment
    1