BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE NS 25GA 1IN BLT SQ GRD W/O SHIELD

    MDR report key: 13673042 · Received March 4, 2022

    Report

    Report Number
    1911916-2022-00126
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 18, 2022
    Report Date
    March 7, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED A GRAY COMPONENT WAS WITHIN A BAG OF BLUE COMPONENTS. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. BOTH PHOTOS SHOW A PLASTIC BAG WITH NEEDLE ASSEMBLIES. ONE OF THE BAGS HAS A LABEL THAT IS NOT A BD LABEL AND THESE PRODUCTS ARE NOT SHIPPED IN PLASTIC BAGS. THESE PRODUCTS ARE NOT IN THE ORIGINAL PACKAGING, HAVE BEEN PROCESSED, REPACKAGED AND LABELED SOMEWHERE OUTSIDE OF BD'S CONTROL. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301644, LOT NUMBER 0157515. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. A TREND ANALYSIS WAS PERFORMED FOR THE LAST TWELVE MONTHS FOR THIS MATERIAL NUMBER AND CUSTOMER. THIS IS THE ONLY COMPLAINT DURING THIS PERIOD. BASED ON THE INVESTIGATION AND 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 THE BD NEEDLE NS 25GA 1IN BLT SQ GRD W/O SHIELD EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OPERATOR FOUND A 27 GAGE CANNULA (GREY HUB) MIXED IN A BAG OF 25 GAGE CANNULA (BLUE HUB).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE NS 25GA 1IN BLT SQ GRD W/O SHIELD EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OPERATOR FOUND A 27 GAGE CANNULA (GREY HUB) MIXED IN A BAG OF 25 GAGE CANNULA (BLUE HUB).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963085 BD NEEDLE NS 25GA 1IN BLT SQ GRD W/O SHIELD HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 0157515

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown