BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL W/BLUNT PLASTIC CANN

    MDR report key: 11478696 · Received March 14, 2021

    Report

    Report Number
    1213809-2021-00127
    Event Type
    Malfunction
    Date Received
    March 14, 2021
    Date of Event
    February 15, 2021
    Report Date
    March 30, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903033486
    PMA / PMN Number
    K974363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: 3/1/2021. H.6. INVESTIGATION: EIGHT PHOTOS AND A BOX CONTAINING THIRTY-EIGHT PACKAGED 10ML SYRINGES WITH BLUNT PLASTIC CANNULA CONFIRMED TO BE FROM BATCH 0010862 (P/N 303348) WERE RECEIVED AND EVALUATED. THIRTY-SIX PHYSICAL PACKAGES WERE FULLY SEALED AND TWO PACKAGES WERE RECEIVED TORN OPEN. THE DEFECTIVE PACKAGES MATCHED THE SAMPLES IN THE PHOTOS. ONE DEFECTIVE PACKAGE HAD ITS TOP WEB TORN OPEN AND THE SYRINGE¿S BLUNT PLASTIC CANNULA WAS FOUND TO BE BENT CLOSE TO THE LUER COLLAR. ONE DEFECTIVE PACKAGE ALSO HAD A TORN TOP WEB, WHILE THE PRODUCT INSIDE WAS NOT DAMAGED. THE GRID FROM THE SEAL WAS CONFIRMED TO BE FULLY PRESENT ON BOTH¿TOP AND BOTTOM¿WEBS OF BOTH PACKAGES, INDICATING THERE WERE NO SEAL ISSUES. MACHINE LOGS WERE REVIEWED, AND PACKAGING PROCESS EVALUATED. INVESTIGATION SHOWED THAT IT IS POSSIBLE A PACKAGE MISALIGNMENT INSIDE THE SHELF CARTON PRIOR TO SEALING COULD RESULT IN THE MISALIGNED PACKAGES NEAR THE TOP OF THE BOX TO GET CRUSHED IN THE TAPE SEALING STATION. THERE WAS A RECORDED INSTANCE OF JAMS IN THE SLITTER STATION, WHICH COULD HAVE CONTRIBUTED TO PACKAGE MISALIGNMENT. IT IS ALSO POSSIBLE OFFLOAD ROBOT JAWS COULD HAVE BECOME OUT OF ALIGNMENT WHEN PLACING PACKAGES INSIDE A SHELF CARTON. BASED ON THE PRODUCTION RECORDS REVIEWED AND INVESTIGATION PERFORMED, THE SCOPE OF THE DEFECT IS LIKELY LIMITED TO A FEW/SEVERAL PIECES IN THE BATCH. THERE IS NO INDICATION THIS DEFECT OCCURRED AT A HIGH RATE DURING THE MANUFACTURE OF BATCH 0010862 (303348). POTENTIAL ROOT CAUSE FOR THE OPEN SEAL DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. PACKAGE MISALIGNMENT LIKELY CONTRIBUTED TO A SITUATION WHERE ONE OR MORE VERTICAL SYRINGES PROCEEDED THROUGH THE TAMPER AND TAPING STATION. DURING THE TAPING PROCESS THESE VERTICAL SYRINGES COULD HAVE BEEN FORCEFULLY TAMPERED THEN SEALED IN THE BOX. THIS POTENTIALLY DAMAGED THE SYRINGES FURTHER TO THE POINT OF BEING UNUSABLE AND COMPROMISED PACKAGE INTEGRITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML LL W/BLUNT PLASTIC CANN HAD DAMAGED PACKAGING BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED ABOUT SEVERAL DAMAGED PACKAGES. THE CUSTOMER HAS EXPERIENCED THE SAME ISSUE BEFORE AND IS STRONGLY COMPLAINING THAT THE ISSUE HAS NOT BEEN RESOLVED."

    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 AN UNSPECIFIED NUMBER OF SYRINGE 10ML LL W/BLUNT PLASTIC CAN HAD DAMAGED PACKAGING BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED ABOUT SEVERAL DAMAGED PACKAGES. THE CUSTOMER HAS EXPERIENCED THE SAME ISSUE BEFORE AND IS STRONGLY COMPLAINING THAT THE ISSUE HAS NOT BEEN RESOLVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375871 SYRINGE 10ML LL W/BLUNT PLASTIC CANN PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 303348 0010862 30382903033486

    Patients

    Seq Age Sex Outcome Treatment
    1