BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML S/T BNS

    MDR report key: 13182763 · Received January 6, 2022

    Report

    Report Number
    1213809-2021-00846
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    December 10, 2021
    Report Date
    December 16, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: TWENTY-THREE LOOSE 10ML SYRINGES (P/N (B)(4) AND SEVENTEEN PHOTOS WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. FOUR SAMPLES FROM WERE OBSERVED TO HAVE EMBEDDED SPOTS OF FOREIGN MATTER PRESENT ON VARIOUS AREAS OF THE BARREL. THE FOREIGN MATTER APPEARED TO BE DEGRADED PLASTIC. THESE SAMPLES WERE NON-CONFORMING PER PRODUCT SPECIFICATION ONE SAMPLE APPEARED TO HAVE A BLACK SMEARING/DOT OF INK ON THE BARREL OPPOSITE THE PRINT AREA. THIS SAMPLE WAS NON-CONFORMING PER PRODUCT SPECIFICATION. TWO SAMPLES WERE OBSERVED TO HAVE MINOR PRINT IMPERFECTIONS, WITH ONE SAMPLE HAVING SMALL BREAKS PRESENT ON THE 4.2-4.8ML GRAD LINES. THE SECOND SAMPLE WAS MISSING PART OF THE "5" NUMERAL BUT DID NOT IMPACT LEGIBILITY. BOTH SAMPLES WERE ACCEPTABLE PER PRODUCT SPECIFICATION. ONE SAMPLE WAS OBSERVED TO HAVE A SEVERELY SKEWED SCALE WITH INK SMEARS/DOTS PRESENT OUTSIDE OF THE PRINT AREA. ADDITIONALLY, DAMAGE WAS OBSERVED OPPOSITE THE SKEWED SCALE. THE SYRINGE WAS NON-CONFORMING PER PRODUCT SPECIFICATION. TWO SYRINGES WERE OBSERVED TO HAVE CRACKED PLUNGER ROD RIBS THAT WERE NON-CONFORMING PER PRODUCT SPECIFICATION. FIVE SAMPLES WERE OBSERVED TO HAVE DAMAGE ON VARIOUS AREAS OF THE BARREL. THE DAMAGE RANGED FROM SEVERE GASHES TO LENGTHWISE CRACKS THAT EXTENDED UP HALF THE LENGTH OF THE BARREL. THESE SYRINGES WERE NON-CONFORMING PER PRODUCT SPECIFICATION. TWO SAMPLES WERE OBSERVED TO HAVE FLANGE DAMAGE THAT CAUSED SHARP PIECES OF PLASTIC TO PROTRUDE. THESE SYRINGES WERE NON-CONFORMING PER PRODUCT SPECIFICATION. SIX SAMPLES HAD MINOR DAMAGE OUTSIDE OF THE PRINT AREA THAT DID NOT SEVERELY GOUGE THE BARREL, IMPACT FUNCTION, OR DAMAGE THE PRINT. THESE SAMPLES WERE ACCEPTABLE PER PRODUCT SPECIFICATION. TECHNICIAN LOGS AND PRODUCTION DATABASES WERE REVIEWED AS PART OF THIS INVESTIGATION WITH NO RELEVANT NOTES FOUND FOR THE COMPLAINT ISSUES. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. 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. POTENTIAL ROOT CAUSE FOR THE BARREL AND PLUNGER ROD DAMAGE IS ASSOCIATED WITH THE ASSEMBLY PROCESS EXCEPT FOR THE SKEWED SCALE/DAMAGED SAMPLE WHICH WAS LIKELY BROUGHT ON BY THE MARKING PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, 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. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SYRINGE 10ML S/T BNS, THE DEVICE EXPERIENCED SCALE MARKING ISSUES, DAMAGED BROKEN PLUNGER RODS, AND DAMAGED DEFORMED PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED SCALE MARKINGS, FM, PLUNGER DEFORMED, BARREL DINGED, CUSTOMER HAS RECEIVED QUITE A FEW PARTS WITH NONCONFORMITIES (SEE ATTACHED). OUR CUSTOMER IS CURRENTLY SORTING. OUT OF THE 19,350 PIECES WERE RECEIVED SO FAR 1,024 PIECE WERE FOUND WITH NONCONFORMITIES. MOST OF THEM WITH FAILURE MODE 4 (FM4) I NEED YOUR HELP WITH BD PART NUMBER 301030, LOT NUMBER 0252682. OUR CUSTOMER HAS RECEIVED QUITE A FEW PARTS WITH NONCONFORMITIES (SEE ATTACHED). OUR CUSTOMER IS CURRENTLY SORTING. OUT OF THE 19,350 PIECES WERE RECEIVED SO FAR 1,024 PIECE WERE FOUND WITH NONCONFORMITIES. MOST OF THEM WITH FAILURE MODE 4 (FM4) (SEE ATTACHED AND BELOW). PLEASE OPEN AN INVESTIGATION AND PROVIDE A FORMAL ROOT CAUSE / CORRECTIVE ACTION REPORT. I HAVE SAMPLES THAT I CAN SEND YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1571713 BD SYRINGE 10ML S/T BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0252682

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown