BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE NS 27GA 1IN BLT SQ GRD W/O SHLD

    MDR report key: 7766287 · Received August 9, 2018

    Report

    Report Number
    1911916-2018-00471
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    May 3, 2018
    Report Date
    September 10, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: PHOTO SAMPLES WERE PROVIDED FOR EVALUATION. BASED UPON REVIEW OF THE ATTACHED PHOTOS THE MIX CONDITION IS VERIFIED. BASED UPON REVIEW OF THE ATTACHED PHOTOS (BOTH SAMPLES ARE IN 27G HUBS AND THE POINTED NEEDLE IS SHORTER THAN THE 1¿ BLUNT SQ GRD) IN COMBINATION WITH REVIEW OF THE DEVICE HISTORY RECORD REVIEW THAT SHOWS A LINE CLEARANCE FROM 27G X ¾ TO 27G X 1 BLT SQ GRD, THIS WOULD INDICATE THERE WAS A LINE CLEARANCE FAILURE. INVESTIGATION CONCLUSION: THE PROBABLE CAUSE IS DUE TO AN INCOMPLETE LINE CLEARANCE PERFORMED BY THE OPERATOR. IT¿S COMMON TO HAVE MULTIPLE LINE CLEARANCE CHANGEOVERS IN ONE DAY WHEN RUNNING OEM ORDERS DUE TO THE QUANTITY VS OUR RUN RATES. WHILE THE OPERATORS ARE TRAINED AND KNOWLEDGEABLE OF CHANGEOVER REQUIREMENTS, INDIVIDUAL PARTS CAN GO UNDETECTED. THIS IS MOST LIKELY DUE TO ISOLATED PARTS REMAINING ON THE LINE AND THEN BEING REINTRODUCED TO THE PRODUCT STREAM. THE PARTS ARE ASSEMBLED IN GROUPS OF 25 PARTS ON A RACK. IF THE LINE WASN¿T CLEARED OF ALL THE ASSEMBLED RACKS, THERE WOULD BE MORE THAN 2 MIXED PARTS. THE TWO MATERIALS USE THE SAME HUBS AND THE SAME CANNULATOR WHEEL. ADDITIONALLY, THEY ARE BOTH BULK BAGGED AT THE ASSEMBLY LINE USING THE SAME CHUTE. CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: B.2. EVENT ATTRIBUTED TO: OTHER. D.8. DEVICE SINGLE USE?: NO. H.3. DEVICE RETURNED TO MANUFACTURER: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ NEEDLE NS 27GA 1IN BLT SQ GRD W/O SHLD HAD MIXED PRODUCT TYPES IN PACKAGING. "TWO SHARP CANNULAS MIXED WITH THE ORDER OF BLUNT CANNULAS." NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ NEEDLE NS 27GA 1IN BLT SQ GRD W/O SHLD HAD MIXED PRODUCT TYPES IN PACKAGING. "TWO SHARP CANNULAS MIXED WITH THE ORDER OF BLUNT CANNULAS." NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607381 BD¿ NEEDLE NS 27GA 1IN BLT SQ GRD W/O SHLD HYPODERMIC NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 7136617

    Patients

    Seq Age Sex Outcome Treatment
    1 Other