BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK¿ TIP

    MDR report key: 9589462 · Received January 14, 2020

    Report

    Report Number
    1213809-2020-00004
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 30, 2019
    Report Date
    January 27, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD 10ML SYRINGE LUER-LOK¿ TIP HAD FOREIGN MATTER, SCALE MARKING ISSUES, AND MOLDING DEFECTS. THIS WAS DISCOVERED BEFORE USE. FOREIGN MATTER OCCURRED ON 14 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301029, BATCH NO.: 7088991, 9003545. IT WAS REPORTED DEFECTIVE MOLDING, FOREIGN MATTER, AND POOR PRINTING. PER SCAR: MATERIAL WAS REJECTED THROUGH A CUSTOMER COMPLAINT DUE TO THE FOLLOWING CONDITION: IT WAS REPORTED "DEFECTIVE MOLDING, FOREIGN MATTER AND POOR PRINTING".

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: FIFTEEN PHOTOS OF LOOSE 10ML SYRINGES AND ONE PHOTO OF A STOPPER ATTACHED TO A PLUNGER ROD WERE RECEIVED AND EVALUATED. ELEVEN WERE FROM BATCH 7088991 AND FIVE WERE FROM BATCH 9003545. EIGHT OF THE PHOTOS APPEARED TO DISPLAY BROWN AND BLACK EMBEDDED FOREIGN MATTER PARTICLES. THE EMBEDDED PARTICLES ARE LIKELY BURNT PLASTIC WITH THREE OF THE SYRINGES IN THE PHOTO CONTAINING PARTICLES LARGER THAN LEVEL 3 IN SIZE AND WERE REJECTABLE PER PRODUCT SPECIFICATION. THE CAVITY AND MOLD NUMBERS OF THE BARRELS WERE NOT VISIBLE ON THE PHOTOS PROVIDED. FIVE OF THE PHOTOS DISPLAYED BLACK FOREIGN MATTER PARTICLES ATTACHED TO THE BARREL THAT APPEARED TO BE INK. THREE OF THE SYRINGES CONTAINED MORE THAN SIX PARTICLES OR ONE PARTICLE LARGER THAN LEVEL 4 IN SIZE AND WERE REJECTABLE PER PRODUCT SPECIFICATION. ONE PHOTO DISPLAYED A SYRINGE WITH SOME MISSING PRINT, BUT NO SINGLE ITEM WAS MISSING MORE THAN 50%, WHICH WAS ACCEPTABLE PER PRODUCT SPECIFICATION. ONE PHOTO DISPLAYED THREE WHITE FOREIGN MATTER PARTICLES ON THE STOPPER. THE COMPOSITION OF THE FOREIGN MATTER WAS UNCLEAR BASED ON THE PHOTO, BUT THE PARTICLES APPEARED LARGER THAN LEVEL 2 IN SIZE AND WERE REJECTABLE PER PRODUCT SPECIFICATION. ONE PHOTO DISPLAYED A PLUNGER ROD INSIDE THE BARREL WITH VISIBLE DAMAGE ON THE RINGS ABOVE THE STOPPER. THE DAMAGE OBSERVED WAS REJECTABLE PER PRODUCT SPECIFICATION. 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 FOREIGN MATTER (INK) DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THE SMALL INDIVIDUAL SPOTS MAY HAVE BEEN CAUSED BY A PARTICLE ON THE PAD ROLL. THE LINE OF INK DOTS ARE LIKELY CONTACT SMEARS FROM BARRELS MAKING CONTACT SHORTLY AFTER BEING PRINTED. POTENTIAL ROOT CAUSE FOR THE MISSING SCALE MAY BE ASSOCIATED WITH THE MARKING OR ASSEMBLY PROCESS. IT WAS UNCLEAR IN THE PHOTO IF THE PRINT WAS SCRATCH OFF OR NOT APPLIED PROPERLY. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER ON THE STOPPER IS UNDETERMINED. THE COMPOSITION OF THE OBSERVED FOREIGN MATTER COULD NOT BE DETERMINED BASED ON THE PHOTO PROVIDED. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. POTENTIAL ROOT CAUSE FOR THE DAMAGED PLUNGER ROD IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT WAS LIKELY A DIAL ISSUE THAT CAUSED THE PLUNGER ROD TO NOT SEAT PROPERLY. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 7088991 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9003545, BATCH 9003545 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 10ML SYRINGE LUER-LOK¿ TIP HAD FOREIGN MATTER, SCALE MARKING ISSUES, AND MOLDING DEFECTS. THIS WAS DISCOVERED BEFORE USE. FOREIGN MATTER OCCURRED ON 14 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301029, BATCH NO.: 7088991, 9003545. IT WAS REPORTED DEFECTIVE MOLDING, FOREIGN MATTER, AND POOR PRINTING. PER SCAR: MATERIAL WAS REJECTED THROUGH A CUSTOMER COMPLAINT DUE TO THE FOLLOWING CONDITION: IT WAS REPORTED "DEFECTIVE MOLDING, FOREIGN MATTER AND POOR PRINTING".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 10ML SYRINGE LUER-LOK¿ TIP HAD FOREIGN MATTER, SCALE MARKING ISSUES, AND MOLDING DEFECTS. THIS WAS DISCOVERED BEFORE USE. FOREIGN MATTER OCCURRED ON 14 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301029, BATCH NO.: 7088991, 9003545. IT WAS REPORTED DEFECTIVE MOLDING, FOREIGN MATTER, AND POOR PRINTING.

    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 #: 7088991, MEDICAL DEVICE EXPIRATION DATE: 2022-03-31, DEVICE MANUFACTURE DATE: 2017-03-29, MEDICAL DEVICE LOT #: 9003545, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2019-01-03. 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 10ML SYRINGE LUER-LOK¿ TIP HAD FOREIGN MATTER, SCALE MARKING ISSUES, AND MOLDING DEFECTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301029 BATCH NO.: 7088991, 9003545. IT WAS REPORTED DEFECTIVE MOLDING, FOREIGN MATTER, AND POOR PRINTING. PER SCAR: MATERIAL WAS REJECTED THROUGH A CUSTOMER COMPLAIN DUE TO THE FOLLOWING CONDITION: IT WAS REPORTED "DEFECTIVE MOLDING, FOREIGN MATTER AND POOR PRINTING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52377 BD 10ML SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other