BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 11307137 · Received February 10, 2021

    Report

    Report Number
    1911916-2021-00103
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 14, 2021
    Report Date
    February 12, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106 AND LOT NUMBER 0051110. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A NEEDLE ASSEMBLY WITH THE PLASTIC SHIELD. IT HAS A DOUBLE NEEDLE. IT COULD BE POSSIBLE FOR THIS DEFECT TO OCCUR DURING THE ASSEMBLY PROCESS. DURING PRODUCTION, THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR, THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE WHITE EPOXY TO FIX IT. IN THIS CASE, THE MISFEEDING OF THE CANNULATOR MAY HAVE INDUCED THE DOUBLE NEEDLE. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. H3. OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 30X1/2 RB CANNULA PIERCED THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305106. BATCH NO: 0051110. IT WAS REPORTED THE NEEDLE WAS NOT ATTACHED PROPERLY. IT HAD POKED OUT A LITTLE BIT FROM THE CAP. VERBATIM: NO SPECIFIC PROCEDURE JUST OPENING UP PRODUCT. JUST AS THE PROVIDER AT THE OFFICE WAS ABOUT TO USE THE NEEDLE IT WAS NOT ATTACHED PROPERLY. IT HAD POKED OUT A LITTLE BIT FROM THE CAP, NO NEEDLE STICK HAD OCCURRED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 30X1/2 RB CANNULA PIERCED THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305106, BATCH NO: 0051110. IT WAS REPORTED THE NEEDLE WAS NOT ATTACHED PROPERLY. IT HAD POKED OUT A LITTLE BIT FROM THE CAP. VERBATIM: NO SPECIFIC PROCEDURE JUST OPENING UP PRODUCT. JUST AS THE PROVIDER AT THE OFFICE WAS ABOUT TO USE THE NEEDLE IT WAS NOT ATTACHED PROPERLY. IT HAD POKED OUT A LITTLE BIT FROM THE CAP, NO NEEDLE STICK HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204475 NEEDLE 30X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 0051110 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1