BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INTEGRA¿ SYRINGE

    MDR report key: 16076222 · Received December 30, 2022

    Report

    Report Number
    2243072-2022-02253
    Event Type
    Malfunction
    Date Received
    December 30, 2022
    Date of Event
    December 12, 2022
    Report Date
    February 7, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). THE REPORTED LOTS 2216568 AND 2243842 DO NOT MATCH ANY MATERIAL NUMBERS ASSOCIATED WITH THE REPORTED PRODUCT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF BATCH: 2243842. THE DEVICE HISTORY RECORD REVIEW FOR LOT NUMBER: 2216568 AND PREVIOUS INVESTIGATIONS PERFORMED FOR THIS REPORT SHOW A POTENTIAL MANUFACTURING RELATED ISSUE WAS PRESENT. AN IN-DEPTH ANALYSIS OF THE PRODUCTION PROCESS IS CURRENTLY IN PROGRESS TO IDENTIFY A ROOT CAUSE FOR THIS POTENTIAL ISSUE AND PREVENT FURTHER RECURRENCE. AGAIN, WITHOUT THE PHYSICAL SAMPLE, THE REPORT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 UNSPECIFIED BD INTEGRA¿ SYRINGES EACH FROM THE REPORTED LOTS 2216568 AND 2243842 FAILED TO RETRACT THEIR NEEDLES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BUTTON IS NOT RETRACTING."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 UNSPECIFIED BD INTEGRA¿ SYRINGES EACH FROM THE REPORTED LOTS: 2216568 AND 2243842 FAILED TO RETRACT THEIR NEEDLES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BUTTON IS NOT RETRACTING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354477 UNSPECIFIED BD INTEGRA¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown