BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL BNS

    MDR report key: 11566171 · Received March 24, 2021

    Report

    Report Number
    1213809-2021-00161
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    January 8, 2021
    Report Date
    April 6, 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

    H6: INVESTIGATION SUMMARY: SEVEN LOOSE 3ML SYRINGES WERE RECEIVED AND EVALUATED. ONE SYRINGE HAD A LOOSE SMALL BROWN FOREIGN MATTER FIBER OUTSIDE THE FLUID PATH NEAR THE BOTTOM OF THE PLUNGER ROD. THE FIBER APPEARED TO BE A PIECE OF CARDBOARD AND WAS LARGER THAN LEVEL 3 IN SIZE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE HAD A LOOSE SMALL BROWN FOREIGN MATTER PARTICLE OUTSIDE THE FLUID PATH NEAR THE BOTTOM OF THE PLUNGER ROD. THE PARTICLE HAD A PENCIL SHAVING-LIKE APPEARANCE, BUT THE COMPOSITION COULD NOT BE VISUALLY DETERMINED. ONE SYRINGE HAD A SMALL WHITE FIBER ATTACHED TO THE OUTSIDE OF THE BARREL NEAR THE COLLAR AND SMALL BLACK EMBEDDED FOREIGN MATTER PARTICLES NEAR THE TOP OF THE BARREL. THE WHITE FIBER APPEARED TO BE A PORTION A STICKER USED TO MARK BAGS OF PRODUCT AND WAS LARGER THAN LEVEL 3 IN SIZE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. THE EMBEDDED PARTICLES APPEARED TO BE BURNT PLASTIC AND WERE ALL SMALLER THAN LEVEL 3 IN SIZE, WHICH WERE ACCEPTABLE PER PRODUCT SPECIFICATION. TWO SYRINGES HAD A SMALL SCUFF OR SCRATCH THAT APPEARED TO BE COSMETIC IN NATURE AND DID NOT AFFECT THE FORM FIT OR FUNCTION OF THE DEVICE, WHICH WERE ACCEPTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE HAD A SIGNIFICANT OVAL SHAPED INDENTATION APPROXIMATELY 0.75" IN LENGTH. THE INDENTATION WAS CENTERED NEAR THE 1ML MARKING AND WAS REJECTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE HAD MISSING PRINT ON THE "1" OF THE 1ML MARKING. THE PRINT WAS MISSING MORE THAN 50%, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER CARDBOARD AND STICKER DEFECTS ARE ASSOCIATED WITH THE MATERIAL HANDLING PROCESS. THE CARDBOARD WAS LIKELY INADVERTENTLY INTRODUCED DURING THE PREPPING OF THE BOX OR DURING THE CLOSING OF THE BOX. THE STICKER WAS LIKELY INADVERTENTLY INTRODUCED DURING THE BAGGING OF THE MOLDED BARRELS. THE LOOSE UNKNOWN PARTICLE COULD NOT BE CONFIRMED TO ORIGINATE FROM THE MANUFACTURING SITE. THE PARTICLE WAS LOOSE, AND THE PRODUCT IS SOLD AS NON-STERILE. POTENTIAL ROOT CAUSE FOR THE BLACK EMBEDDED FOREIGN MATTER IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FM 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. THE POTENTIAL ROOT CAUSE FOR THE DAMAGE AND/OR SCRATCHES DEFECTS ARE ASSOCIATED WITH THE ASSEMBLY PROCESS. THE POTENTIAL ROOT CAUSE FOR THE MISSING PRINT IS ASSOCIATED WITH THE MARKING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON ANY OF THE DEFECTIVE RATES IDENTIFIED. BATCH 9178295 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 3ML LL BNS WAS DAMAGED, HAD FOREIGN MATTER, AND SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301073 BATCH NO.: 9178295. IT WAS REPORTED THAT SYRINGES EITHER HAVE DIRT, FOREIGN OBJECTS, SCRATCHES, OR FADED PRINTING.

    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 BNS WAS DAMAGED, HAD FOREIGN MATTER, AND SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301073 BATCH NO.: 9178295 IT WAS REPORTED THAT SYRINGES EITHER HAVE DIRT, FOREIGN OBJECTS, SCRATCHES, OR FADED PRINTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461549 SYRINGE 3ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9178295

    Patients

    Seq Age Sex Outcome Treatment
    1