BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 15818303 · Received November 17, 2022

    Report

    Report Number
    1213809-2022-01027
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    October 21, 2022
    Report Date
    December 11, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059010
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION?: YES. D10: RETURNED TO MANUFACTURER ON: 07DEC2022 H6: INVESTIGATION SUMMARY IT WAS REPORTED NEEDLES WERE CAUSING RESISTANCE. TO AID IN THE INVESTIGATION, THIRTY-EIGHT SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ALL THIRTY-EIGHT SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305901, LOT NUMBER 2202902. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 2202902 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. PREVIOUS INVESTIGATIONS HAVE REVEALED THAT PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON OUR MANUFACTURING LINE TO ENSURE THAT THE NEEDLE LUBRICANT APPLICATION IS PROPERLY APPLIED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE NEEDLE LUBRICANT IS APPLIED UNIFORMLY TO THE NEEDLE. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF 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

    IT WAS REPORTED THAT 21 BD SAFETYGLIDE¿ NEEDLES WERE BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE 21 DEFECTIVE NEEDLES WERE THE 1"- LOT # 2024138; EXP 12/31/26. THAT WAS ONLY AN EXAMPLE OF SOMETHING THAT I EXPERIENCED MYSELF DURING OUR FLU CLINIC AS THESE WERE THE ONLY NEEDLES THAT WE HAD AVAILABLE THAT DAY. DURING THAT SPECIFIC INCIDENT I WENT THROUGH A TOTAL OF 26 NEEDLES TO CONNECT TO 5 PREFILLED SYRINGES (21 DEFECTIVE AND 5 WITHOUT ISSUE). THERE WERE SEVERAL OTHERS THAT DAY, BUT NOT NEARLY THAT MANY EACH TIME. THROUGH DISCUSSION W/ OUR NURSES I DISCOVERED THAT THEY HAVE ALSO BEEN HAVING TROUBLE OVER THE LAST COUPLE OF WEEKS. NONE OF THEM THOUGHT MUCH OF IT AT FIRST AS IT'S NOT SUPER UNCOMMON TO HAVE A DEFECTIVE NEEDLE HERE AND THERE. THATS WHY IT'S IMPORTANT TO ALWAYS CHECK AND MAKE SURE THE END LOOKS OK AND THAT YOU GET THE DROP OF THE MED/VACCINE AT THE END. THEY DISCOVERED IT WAS A PROBLEM WHEN EACH OF THEM EXPERIENCED SOMETHING SIMILAR AND THEN MORE THAN ONCE. I ALSO RECENTLY GAVE ONE OF OUR NURSES HER FLU SHOT AND THOUGHT THE INJECTION WAS SLOWER THAN NORMAL AND THE NEEDLE DIDN'T GO IN AS QUICKLY AS USUAL. I THOUGHT MAYBE IT WAS JUST ME UNTIL OTHER NURSES SAID THEY TOO HAD EXPERIENCED THAT A TIME OR TWO OVER THE LAST COUPLE OF WEEKS. ONE NURSE ALSO COMPLAINED THAT SHE MET RESISTANCE AT FIRST AND THEN ALL AT ONCE THE MEDICATION SHE WAS GOING TO GIVE CAME SHOOTING THROUGH THE END ABRUPTLY AND HAD TO WASTE THE DOSE. I ALSO THOUGHT IT WAS JUST AN ISSUE W/ ONE OF THE BOXES, HOWEVER, WE HAVE NOTICED W/ EACH BOX WE HAVE OPENED. AS FOR THE ADVERSE EVENTS, ONE OF OUR NEWER NURSES DID END UP HAVING TO STICK A PATIENT TWICE AS WHEN SHE INITIALLY INJECTED THE PATIENT, SHE COULDN'T GET THE VACCINE TO GO THROUGH. IN THAT CASE I WAS TOLD THAT SHE DID CHECK THE END AND ALSO WAS ABLE TO GET THE DROP AT THE END OF THE NEEDLE INDICATING THAT IT WAS PRIMED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 21 BD SAFETYGLIDE¿ NEEDLES WERE BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE 21 DEFECTIVE NEEDLES WERE THE 1"- LOT#: 2024138; EXP: 12/31/26. THAT WAS ONLY AN EXAMPLE OF SOMETHING THAT I EXPERIENCED MYSELF DURING OUR FLU CLINIC AS THESE WERE THE ONLY NEEDLES THAT WE HAD AVAILABLE THAT DAY. DURING THAT SPECIFIC INCIDENT I WENT THROUGH A TOTAL OF 26 NEEDLES TO CONNECT TO 5 PREFILLED SYRINGES (21 DEFECTIVE AND 5 WITHOUT ISSUE). THERE WERE SEVERAL OTHERS THAT DAY, BUT NOT NEARLY THAT MANY EACH TIME. THROUGH DISCUSSION W/ OUR NURSES I DISCOVERED THAT THEY HAVE ALSO BEEN HAVING TROUBLE OVER THE LAST COUPLE OF WEEKS. NONE OF THEM THOUGHT MUCH OF IT AT FIRST AS IT'S NOT SUPER UNCOMMON TO HAVE A DEFECTIVE NEEDLE HERE AND THERE. THAT'S WHY IT'S IMPORTANT TO ALWAYS CHECK AND MAKE SURE THE END LOOKS OK AND THAT YOU GET THE DROP OF THE MED/VACCINE AT THE END. THEY DISCOVERED IT WAS A PROBLEM WHEN EACH OF THEM EXPERIENCED SOMETHING SIMILAR AND THEN MORE THAN ONCE. I ALSO RECENTLY GAVE ONE OF OUR NURSES HER FLU SHOT AND THOUGHT THE INJECTION WAS SLOWER THAN NORMAL AND THE NEEDLE DIDN'T GO IN AS QUICKLY AS USUAL. I THOUGHT MAYBE IT WAS JUST ME UNTIL OTHER NURSES SAID THEY TOO HAD EXPERIENCED THAT A TIME OR TWO OVER THE LAST COUPLE OF WEEKS. ONE NURSE ALSO COMPLAINED THAT SHE MET RESISTANCE AT FIRST AND THEN ALL AT ONCE THE MEDICATION SHE WAS GOING TO GIVE CAME SHOOTING THROUGH THE END ABRUPTLY AND HAD TO WASTE THE DOSE. I ALSO THOUGHT IT WAS JUST AN ISSUE W/ ONE OF THE BOXES, HOWEVER, WE HAVE NOTICED W/ EACH BOX WE HAVE OPENED. AS FOR THE ADVERSE EVENTS, ONE OF OUR NEWER NURSES DID END UP HAVING TO STICK A PATIENT TWICE AS WHEN SHE INITIALLY INJECTED THE PATIENT, SHE COULDN'T GET THE VACCINE TO GO THROUGH. IN THAT CASE I WAS TOLD THAT SHE DID CHECK THE END AND ALSO WAS ABLE TO GET THE DROP AT THE END OF THE NEEDLE INDICATING THAT IT WAS PRIMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2834151 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2202902 00382903059010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown