BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® MULTIPLE USE DRAWING NEEDLE 21G X 1 1/4" GREEN

    MDR report key: 15110688 · Received July 27, 2022

    Report

    Report Number
    8020040-2022-00019
    Event Type
    Malfunction
    Date Received
    July 27, 2022
    Report Date
    September 23, 2022
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    FMI
    PMA / PMN Number
    K973620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). NO DATE OF THE EVENT COULD BE OBTAINED FROM THE CUSTOMER. SAMPLES OR MORE INFORMATION ON THE TYPE OF PRODUCT WERE REQUESTED TO BE ABLE TO INVESTIGATE THE ALLEGED EVENT. AS SOON AS WE HAVE RESULTS ON THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    COMPLAINT STATEMENT (B)(4): RECEIVED 83 PCS 450062/21F02C AND 94 PCS 450061/21G23C FOR EVALUATION. NO PICTURES WERE PROVIDED. WE HAVE NO REMAINING INVENTORY OF EITHER MATERIAL/BATCH. WE FORWARDED THE COMPLAINT AND CUSTOMER SAMPLES TO OUR SUPPLIER FROM WHICH WE RECEIVE THESE PRODUCTS. ACCORDING TO THEIR INVESTIGATION AND COMMENTS, MANUFACTURING AND INSPECTION RECORDS OF THE CONCERNED MATERIALS/BATCHES WERE REVIEWED, AND NO ABNORMALITIES WHICH COULD BE RELATED TO THE REPORTED EVENTS WERE OBSERVED. RETAIN AND CUSTOMER SAMPLES FOR 450062/21F02C WERE VISUALLY EXAMINED. NO ABNORMALITIES SUCH AS BENT NEEDLE TUBES, DAMAGES OR MOLDING DEFECT OF NEEDLE HUBS OR RUBBER SLEEVES WERE FOUND. FITTING FORCE TEST WAS PERFORMED ON BOTH THE RETAIN AND CUSTOMER SAMPLES OF 450062/21F02C BY SCREWING THEM INTO A HOLDER. THE MEASUREMENTS SHOWED RESULTS WITHIN THE SPECIFICATION; AND ALL COULD BE SCREWED INTO THE HOLDER WITHOUT ANY BREAKAGE. FURTHERMORE, THE FITTING STRENGTH OF THE RUBBER SLEEVE WAS MEASURED ON 450062/21F02C RETURNED SAMPLES, AND ALL WERE WITHIN THE NORMAL RANGE. RETAIN AND CUSTOMER SAMPLES FOR 450061/21G23C WERE VISUALLY EXAMINED. NO ABNORMALITIES SUCH AS BENT NEEDLE TUBES, DAMAGES OR MOLDING DEFECT OF NEEDLE HUBS OR RUBBER SLEEVES WERE FOUND. FITTING FORCE TEST WAS PERFORMED ON 450061/21G23C CUSTOMER RETURNED SAMPLES BY SCREWING THEM INTO A HOLDER. THE MEASUREMENTS SHOWED RESULTS WITHIN THE SPECIFICATION; AND ALL COULD BE SCREWED INTO THE HOLDER WITHOUT ANY BREAKAGE. RETAIN AND CUSTOMER SAMPLES FOR BOTH LOTS WERE CONNECTED TO GREINER STANDARD HOLDER AND GREINER BLOOD COLLECTION TUBE FOR WATER SAMPLING. NO DAMAGE ON NEEDLE TUBE OR DAMAGE/SEPARATION OF NEEDLE HUB FROM SCREW THREAD WAS OBSERVED. THE ALLEGED EVENT CANNOT BE DUPLICATED. CORRECTED DATA: D1, D2, D4: SUSPECT MEDICAL DEVICE; H3: RECEIVED SAMPLES; H6: HEALTH IMPACT, MEDICAL DEVICE PROBLEM, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H10: MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    CUSTOMER STATES NEEDLE STICK INJURY. THIS OCCURRED AFTER PATIENT BLOOD COLLECTION, WHEN ACTIVATING SAFETY. THE PHLEBOTOMIST IS UNABLE TO EXPLAIN EXACTLY WHAT HAPPENED DURING THE NEEDLE STICK OR WHAT CAUSED. THE NEEDLE AND SAFETY WERE STILL ATTACHED TO THE HOLDER WHEN THE NEEDLE STICK OCCURRED. CUSTOMER STATES STRAIGHT NEEDLES DISCONNECTING FROM THE QUICKSHIELD HOLDER DURING PATIENT DRAW. THERE HAVE BEEN 6 OCCURRENCES TOTAL WITH 3 DIFFERENT PHLEBOTOMISTS. THERE WAS NO INJURY TO THE PATIENT OR PHLEBOTOMIST. CUSTOMER HAS BEEN USING GREINER NEEDLES AND HOLDERS FOR 3 MONTHS AND THIS JUST STARTED OCCURRING 3 WEEKS AGO. THEY WERE TIGHTENING THE NEEDLE INTO THE HOLDER JUST UNTIL SNUG BUT DUE TO THESE RECENT OCCURRENCES, YESTERDAY THEY STARTED TO REALLY TIGHTEN AS TIGHT AS YOU CAN GET THE NEEDLE WITH THE HOLDER. WITH THE VERY LAST OCCURRENCE TODAY, THE RUBBER ALSO CAME OFF THE BACK-END NEEDLE AFTER 3 TUBES WERE COLLECTED. GBO PRODUCT SPECIALIST ADVISED CUSTOMER TO ONLY TIGHTENED UNTIL SNUG, DO NOT OVERTIGHTEN CUSTOMER STATES NEEDLES DID NOT STAY ATTACHED TO HOLDER. THERE WERE 2 OCCURRENCES WITH THE QUICKSHIELD HOLDER AND STRAIGHT NEEDLE WHERE THERE WAS NO RESISTANCE WHEN SCREWING IN THE NEEDLE INTO THE HOLDER. THE NEEDLE KEPT TURNING AND DID NOT ATTACH TO THE HOLDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666593 VACUETTE® MULTIPLE USE DRAWING NEEDLE 21G X 1 1/4" GREEN CANNULA FMI GREINER BIO-ONE GMBH 450061, 450062 21G23C, 21F02C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown