BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLES AND SYRINGES

    MDR report key: 7704797 · Received July 19, 2018

    Report

    Report Number
    1213809-2018-00437
    Event Type
    Malfunction
    Date Received
    July 19, 2018
    Date of Event
    June 26, 2018
    Report Date
    August 24, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059172
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MULTIPLE PHOTOS WERE RECEIVED AND EVALUATED. PHOTOS DEPICTED PACKAGED SAFETYGLIDE PRODUCT CONFIRMED TO BE FROM BATCH 7212773 (B)(4). ONE PHOTO SHOWED TWO CONNECTED PACKAGES WITH SEALED PRODUCT. THE 2 NEEDLES INSIDE HAD DIFFERENT COLORED HUBS - ONE WAS GREEN (21G) AND ONE WAS PINK (18 G). IN ADDITION, OTHER PHOTOS SHOWED 2 STRIPS OF PRODUCT WITH BATCH NUMBERS STARTED OFF PRINTED ON THE PACKAGES AND GRADUALLY PRINT GOING OFF THE PACKAGES UNTIL NONE WAS PRESENT. ANOTHER STRIP WAS OBSERVED WITH NO BATCH/EXPIRATION DATE. FINALLY, A STRIP OF PACKAGES WAS DEPICTED WITH PART OF RED SPLICE TAPE ON THE EDGE OF THE PACKAGES. THE TAPE WAS ON THE OUTSIDE OF THE PACKAGES¿ TOP WEB AND DID NOT HAVE ANY EFFECT ON THE PACKAGE INTEGRITY. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. LINE CLEARANCE WAS RECORDED PERFORMED AS PER REQUIREMENT AT THE START OF THE COMPLAINT BATCH 7212773.(B)(4). 33 HOURLY IN-PROCESS INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO ISSUES RECORDED. 4 ADDITIONAL INSPECTIONS WERE PERFORMED ON PALLETS 1, 7, 13 AND 19 WITH NO ISSUES RECORDED. MACHINE LOGS WERE CHECKED AND ISSUES WITH PRINTER COMMUNICATION WERE RECORDED AND CORRECTED, WHICH WOULD DIRECTLY IMPACT THE TIMING OF BATCH PRINTING ON THE TOP WEB. MACHINE¿S ENTIRE BATCH AND EXPIRATION DATE PRINTING SYSTEM WAS RECENTLY UPGRADED TO IMPLEMENT UNIQUE DEVICE IDENTIFIER. THE SETUP PRESENT DURING THE MANUFACTURE OF THE COMPLAINT BATCH NO LONGER EXISTS. CURRENT MACHINE SPLICE DETECTORS WERE VERIFIED TO BE FUNCTIONING PROPERLY. INVESTIGATION CONCLUSION: 1. MIXED PRODUCT LIKELY OCCURRED DUE TO INSUFFICIENT LINE CLEARANCE. IT IS POSSIBLE FOR A FEW 18GA NEEDLES FROM PREVIOUS BATCH TO NOT HAVE BEEN CLEARED AND ENDED UP GETTING MIXED IN WITH THE COMPLAINT BATCH. 2. CUT-OFF BATCH/EXPIRY COMMUNICATION ISSUE WITH PRINTER, ALLOWING MACHINE TO ADVANCE PACKAGED PRODUCT WHILE BATCH/EXPIRY PRINTING WAS IN PROGRESS. 3. SPLICE TAPE INABILITY TO DETECT INCOMPLETE SPLICE SEGMENTS. LOCATION OF THE SPLICE TAPE DID NOT ALIGN WITH SENSOR POSITION DUE TO BEING AN INCOMPLETE SPLICE PIECE. CORRECTIVE AND OR PREVENTIVE ACTION. 1. CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN IMPLEMENTED, APPLIES FOR MIXED PRODUCT. 2. THE ENTIRE PRINTER SETUP WAS REDESIGNED FOR INIQUE DEVICE IDENTIFIER. THE OLD PRINTER SETUP NO LONGER EXISTS. NO ADDITIONAL ACTIONS ARE NECESSARY AT THIS TIME. 3. THE SPLICE TAPE IS A COSMETIC DEFECT AS IT DOES NOT HAVE ANY EFFECT ON THE PACKAGE INTEGRITY. THE DEFECT IS LIMITED TO THE SHOTS BEING SPLICED. NO CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAFETYGLIDE¿ NEEDLES AND SYRINGES WITH DIFFERENT GAUGES WERE MISS LABELED, MIXED PRODUCT, AND HAD NO EXPIRATION DATES. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAFETYGLIDE NEEDLES AND SYRINGES WITH DIFFERENT GAUGES WERE MISS LABELED, MIXED PRODUCT, AND HAD NO EXPIRATION DATES. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 · 1

    IT WAS REPORTED THAT BD SAFETYGLIDE¿ NEEDLES AND SYRINGES WITH DIFFERENT GAUGES WERE MISS LABELED, MIXED PRODUCT, AND HAD NO EXPIRATION DATES. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544624 BD SAFETYGLIDE¿ NEEDLES AND SYRINGES SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 7212773 30382903059172

    Patients

    Seq Age Sex Outcome Treatment
    1 Other