BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ HYPODERMIC NEEDLE

    MDR report key: 16632956 · Received March 28, 2023

    Report

    Report Number
    3002682307-2023-00082
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    February 15, 2023
    Report Date
    March 20, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301750 AND LOT NUMBER 220902. 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 WITHIN SPECIFICATIONS. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. UNFORTUNATELY, DURING THE SAMPLE SHIPMENT PROCESS FOR FOURIER-TRANSFORM INFRARED (FTIR) SPECTROSCOPY ANALYSIS, THE SAMPLE BECAME LOST. AFTER SEVERAL ATTEMPTS TO LOCATE THE SAMPLE WITHOUT SUCCESS, AN INVESTIGATION WITHOUT THE SAMPLE WAS COMPLETED. IF THE SAMPLE IS FOUND, A REVISED INVESTIGATION WILL BE PERFORMED. WE APOLOGIZE FOR THE INCONVENIENCE. A VIDEO SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE VIDEO SHOWED A NEEDLE IN WHICH THE LIQUID WAS SPLIT INTO TWO. THIS MAY RESULT IF SOME MATERIAL IS PARTIALLY OBSTRUCTING THE CANNULA. PER THE PROVIDED FEEDBACK AND VIDEO, WE UNDERSTAND THAT THE NEEDLE WAS CLOGGED DURING USE, WHEN PIERCING THE RUBBER STOPPER. THIS TYPE OF DEFECT HAS BEEN INVESTIGATED IN THE PAST, WITH FTIR ANALYSIS AND SIMULATED STUDIES PERFORMED WITH MULTIPLE CONTAINER TYPES AND NEEDLES. THE HISTORICAL ANALYSIS OF CLOGGED NEEDLES OF SIMILAR INCIDENTS REVEALS A CONICAL SHAPE, SOFT TRANSPARENT MATERIAL WITH A FLAT SURFACE WITH FTIR RESULTS IDENTIFYING THE MATERIAL AS POLYETHYLENE (PE). IT WAS OBSERVED THAT THESE TYPES OF PARTICLES ARE COMMONLY GENERATED WHEN NEEDLES ARE USED TO ACCESS THE SEPTUM OF RIGID PLASTIC CONTAINERS OF SALINE OR OTHER MEDICATION SOLUTIONS. FURTHER INVESTIGATION SUGGESTED THAT THE BD MICROLANCE¿ NEEDLE HAD BEEN USED TO ACCESS RIGID PLASTIC CONTAINERS OF SALINE OR OTHER MEDICATION SOLUTIONS DESIGNED TO HAVE A DOUBLE SEPTUM, THE FIRST IS A NORMAL RUBBER CLOSURE, THE SECOND IS A THICK POLYETHYLENE SEPTUM. ACCORDING TO THE ABOVE CONCLUSIONS, WE HAVE TO CONSIDER THAT BD MICROLANCE¿ NEEDLES ARE DESIGNED AND MANUFACTURED IN ACCORDANCE WITH ISO STANDARDS AND WHOSE PRIMARY USE IS INTENDED TO PENETRATE THE SKIN AND RUBBER CLOSURES OF VIALS. THEY ARE NOT DESIGNED TO PENETRATE THICK POLYETHYLENE MEMBRANES. DEDICATED DEVICES ARE AVAILABLE FROM THE SUPPLIER OF THE RIGID PLASTIC CONTAINERS. BD RECOMMENDS CONTACTING THE MANUFACTURER OF THE CONTAINER FOR A DETAILED LIST OF THESE ACCESSORIES. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. 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

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ HYPODERMIC NEEDLE WAS CLOGGED DURING USE DUE TO NEEDLE CORING RUBBER STOPPER OF VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SEEM CLOGGED AND DIFFICULT TO SQUEEZE LIQUID THROUGH THE NEEDLE TIP. THESE WHITE TIPS APPEAR TO "PIERCE THE RUBBER MEMBRANE THROUGH WHICH IT IS PIERCED", LEAVING A SMALL RUBBER STOPPER INSIDE. WE USE THESE A LOT, AND IT CONSTANTLY HAPPENS THAT THEY SEEM CLOGGED AND THAT IT IS VERY DIFFICULT TO SQUEEZE LIQUID OUT THROUGH THE NEEDLE TIP... ON THE VIDEO I PUSH VERY HARD, BUT THERE IS ONLY A THIN JET OF LIQUID".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767213 BD MICROLANCE¿ HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220902

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown