BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLES

    MDR report key: 14226265 · Received April 27, 2022

    Report

    Report Number
    3002682307-2022-00129
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    March 22, 2022
    Report Date
    June 6, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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

    INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 210910. 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. IN REGARD TO THE REPORTED ISSUE OF AN EXTRA HOLE FOUND ALONG THE NEEDLE SHAFT, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED. THE RETAINED SAMPLES WERE ASSEMBLED WITH A BD DISCARDIT SYRINGE AND NO SIGNS OF LEAKAGE OR DEFECT COULD BE DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROLANCE¿ 3 NEEDLES LEAKAGE OCCURRED BECAUSE OF A DEFECTIVE NEEDLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 11/04 UPDATE RECEIVED: DESCRIPTION OF INCIDENT NO 1 ON (B)(6) 2022, CNS ON DUTY WAS INJECTING SYRINGE AND YELLOW NEEDLE (30G X ½¿ LOT 210909 EXP2026-08) SHE FOUND A DEFECT ALONG THE NEEDLE, AN EXTRA HOLE WAS FOUND ALONG THE SHAFT OF NEEDLE TOWARDS THE BASE, APPROXIMATELY 3MM FROM THE BASE. THIS DEFECT CAUSED A WASTE OF THE MEDICATION AND THE PATIENT MIGHT NOT HAVE RECEIVED THE CORRECT DOSE OF MEDICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROLANCE¿ 3 NEEDLES LEAKAGE OCCURRED BECAUSE OF A DEFECTIVE NEEDLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 11/04 UPDATE RECEIVED: DESCRIPTION OF INCIDENT NO 1: ON 22/03/22, CNS ON DUTY WAS INJECTING SYRINGE AND YELLOW NEEDLE (30G X ½¿ LOT 210909 EXP2026-08-PLEASE SEE BELOW PHOTO ) SHE FOUND A DEFECT ALONG THE NEEDLE, AN EXTRA HOLE WAS FOUND ALONG THE SHAFT OF NEEDLE TOWARDS THE BASE, APPROXIMATELY 3MM FROM THE BASE. THIS DEFECT CAUSED A WASTE OF THE MEDICATION AND THE PATIENT MIGHT NOT HAVE RECEIVED THE CORRECT DOSE OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096889 BD MICROLANCE¿ 3 NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 210910

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown