BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE 3 NEEDLES 21G 1 1/2IN

    MDR report key: 17966664 · Received October 19, 2023

    Report

    Report Number
    3002682307-2023-00310
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    October 4, 2023
    Report Date
    December 27, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903044320
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304432 AND LOT NUMBER 211205. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLE, THE NEEDLE WAS OBSERVED CLOGGED DUE TO MEDICATION. HALF OF THE HUB HAD MEDICATION (WHITE SUBSTANCE) WITHIN IT AND THE CANNULA WAS OBSTRUCTED WITH THE SAME SUBSTANCE. TO FURTHER INVESTIGATE THIS ISSUE, TWENTY (20) RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED NEEDLE SAMPLES WERE ASSEMBLED WITH A DISCARDIT 2ML SYRINGE AND LIQUID WAS FOUND TO MOVE NORMALLY THROUGH THE NEEDLE SAMPLES WITHOUT ANY SIGNS OF CLOGGING OR DEFECT. BASED ON THE SAMPLE RESULTS, IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED FROM THE MEDICATION USED. IN CERTAIN CIRCUMSTANCES, THE DRUG USED CAN BECOME DEPOSITED WITHIN THE CANNULA, CAUSING THE NEEDLE TO BLOCK DUE TO CRYSTALLIZATION. OCCLUSION IS MOST LIKELY TO OCCUR IF THE DRUG REMAINS IN THE NEEDLE FOR AN EXTENDED PERIOD OF TIME. DURING THE PRODUCTION PROCESS, CANNULAS ARE ROUTINELY INSPECTED FOR OCCLUSION AFTER ASSEMBLY. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICROLANCE 3 NEEDLES 21G 1 1/2IN NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM SWEDISH TO ENGLISH: A COMPLAINT REPORTED BY THE PHARMACY ON BEHALF OF A CUSTOMER REGARDING DECAPEPTYL DEPOT, BATCH V14298E: THE SUSPENSION WAS CREATED AS PER INSTRUCTION, HOWEVER THE SUSPENSION COULD NOT BE INJECTED IM. AS THE CANULA WAS CLOGGED. NO EXACT MEASURES WERE INDICATED, HOWEVER, AS NO MISSED DOSE WAS REPORTED IT IS ASSUMED THAT A NEW UNIT WAS USED. NO SERIOUS INJURY NOR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94092 BD MICROLANCE 3 NEEDLES 21G 1 1/2IN CONVENTIONAL NEEDLES FMI BECTON DICKINSON, S.A. 211205 00382903044320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown