BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL EURO 200 S/C

    MDR report key: 10759447 · Received October 29, 2020

    Report

    Report Number
    1213809-2020-00764
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    October 5, 2020
    Report Date
    November 25, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-11-10. H6: INVESTIGATION SUMMARY: ONE 1ML SYRINGE IN AN OPENED BLISTER PACK FROM BATCH 9073600 (P/N 309658) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE TIP OF THE PLUNGER ROD WAS BROKEN OFF INSIDE THE STOPPER, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE BROKEN PLUNGER ROD DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 3ML LL EURO 200 S/C HAD THE STOPPER SEPARATE FROM THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " I WOULD LIKE TO CONTACT YOU ABOUT AN ISOLATED QUALITY DEFECT OBSERVED ON A 3 ML SYRINGE (REF: (B)(4) LOT: 9073600) WHERE THERE IS A DISASSOCIATION BETWEEN THE PLUNGER AND THE PLUNGER SEAL. THE DEVICE IS AVAILABLE FOR A POSSIBLE EXPERTISE. THIS DEVICE IS NOT CONTAMINATED BECAUSE IT IS NOT USED IN A PATIENT, NOR DOES IT CONTAIN TRACES OF MEDICATION."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 3ML LL EURO 200 S/C HAD THE STOPPER SEPARATE FROM THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " I WOULD LIKE TO CONTACT YOU ABOUT AN ISOLATED QUALITY DEFECT OBSERVED ON A 3 ML SYRINGE (REF: 309 658, LOT: 9073600) WHERE THERE IS A DISASSOCIATION BETWEEN THE PLUNGER AND THE PLUNGER SEAL. THE DEVICE IS AVAILABLE FOR A POSSIBLE EXPERTISE. THIS DEVICE IS NOT CONTAMINATED BECAUSE IT IS NOT USED IN A PATIENT, NOR DOES IT CONTAIN TRACES OF MEDICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224709 SYRINGE 3ML LL EURO 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309658 9073600 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1