BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML

    MDR report key: 11963319 · Received June 8, 2021

    Report

    Report Number
    3002682307-2021-00246
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 12, 2021
    Report Date
    July 26, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2103238. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. THIS LOT NUMBER WAS PRODUCED IN A PACKAGING LINE FAR FROM THE PACKAGING LINE PRODUCING THE EMERALD 10ML SYRINGES; THEREFORE, AN EXACT MANUFACTURING RELATED CAUSE WAS UNABLE TO BE DETERMINED FOR THIS INCIDENT. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 20ML CAME WITH A MIX OF PRODUCT TYPES. THIS OCCURRED ON 100 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR CUSTOMER HAD ORDERED A BOX OF 960 UNITS OF OUR REFERENCE MDS 300296. UPON RECEIPT, THEY NOTICED THE PRESENCE OF A BOX OF 100 UNITS OF REFERENCE (B)(4) INSIDE THE BOX OF 300296. CERTAINLY AN ERROR IN THE PACKAGING AT THE FACTORY.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE S2 20ML CAME WITH A MIX OF PRODUCT TYPES. THIS OCCURRED ON 100 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR CUSTOMER HAD ORDERED A BOX OF (B)(6) UNITS OF OUR REFERENCE (B)(4). UPON RECEIPT, THEY NOTICED THE PRESENCE OF A BOX OF 100 UNITS OF REFERENCE (B)(4) INSIDE THE BOX OF 300296. CERTAINLY AN ERROR IN THE PACKAGING AT THE FACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850334 SYRINGE S2 20ML SYRINGE FMF BECTON DICKINSON, S.A. 2103238

    Patients

    Seq Age Sex Outcome Treatment
    1