BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 5ML SYRINGE SLIP TIP WITH BD PRECISIONGLIDE¿ NEEDLE 22G 1 1/4

    MDR report key: 14734256 · Received June 17, 2022

    Report

    Report Number
    3002682307-2022-00169
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    May 19, 2022
    Report Date
    July 19, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4) AND LOT NUMBER 1904152. 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. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES WERE OBTAINED. THROUGH EVALUATION OF THE RETAINED SAMPLES, NO SIGNS OF DEFECT COULD BE OBSERVED. BASED ON THE LIMITED INVESTIGATION RESULTS AND THE PROVIDED CUSTOMER FEEDBACK, WE ARE UNABLE TO CONFIRM NOR DETERMINE AN EXACT CAUSE FOR THIS REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD 5ML SYRINGE SLIP TIP WITH BD PRECISIONGLIDE¿ NEEDLE 22G 1 1/4 FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THIS OCCURRED 5 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OPERATING ROOM THE NURSE IN CHARGE FOUND A WHITE FOREIGN MATTER ON THE INNER WALL OF THE SYRINGE DURING SAMPLING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD 5ML SYRINGE SLIP TIP WITH BD PRECISIONGLIDE¿ NEEDLE 22G 1 1/4 FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THIS OCCURRED 5 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OPERATING ROOM THE NURSE IN CHARGE FOUND A WHITE FOREIGN MATTER ON THE INNER WALL OF THE SYRINGE DURING SAMPLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311132 BD 5ML SYRINGE SLIP TIP WITH BD PRECISIONGLIDE¿ NEEDLE 22G 1 1/4 HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 1904152

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown