BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALE LL ADAPTOR

    MDR report key: 11742655 · Received April 28, 2021

    Report

    Report Number
    9616066-2021-50847
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 31, 2021
    Report Date
    September 13, 2021
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: D.4. MEDICAL DEVICE LOT#: 1058001. THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 5/5/2021. H.6. INVESTIGATION: ONE PHOTO AND EIGHT SAMPLES WERE RECEIVED BY THE CUSTOMER FOR INVESTIGATION. UPON VISUAL INSPECTION, IT COULD BE OBSERVED THAT MATERIAL 1001-05-004 (CORRECT P/N) BATCH 1058001 HAD SOME OF ANOTHER PRODUCT MIXED IN . NO OTHER DEFECTS WERE OBSERVED. THE CUSTOMER'S COMPLAINT THAT 300 PIECES WERE FOUND INSIDE THE BAG WITH A BIGGER TUBING WAS VERIFIED. AFTER PERFORMING A PROCESS WALK THROUGH FOR MOLD 8010 ON P/N 1001-085-004 AND REVIEWING THE DEFECT IMAGES WITH THE CROSS-FUNCTIONAL TEAMS AT NAMC, IT WAS DETERMINED THE MOSTLY LIKELY CAUSE OF MIXED PRODUCT IS AN INADEQUATE PERFORMANCE OF LINE CLEARANCE REQUIREMENTS. THE PREVIOUS BATCH RAN A DIFFERENT PART CODE (1005-146-004) WHICH HAS A LARGER TUBE DIMENSION. BASED ON IMAGES AND PARTS RECEIVED, WE CAN PRESUME THAT THIS PRODUCT WAS NOT CLEARED BEFORE PRODUCTION STARTED ON THE 1001-05-004 (CORRECT P/N) MATERIAL. DURING REVIEW OF THE PROCESS NO CATCH POINTS OR MIXED PRODUCT WAS IDENTIFIED. DUE TO THE LARGE VOLUME OF MIXED PARTS OBSERVED (300) WE CAN ASCERTAIN THAT PREVIOUS PRODUCT WAS NOT CLEARED FROM THE BAGGING CAROUSEL BEFORE CHANGING OVER TO A NEW PRODUCT CODE. IN THE COMPLAINT DETAILS, ADDITIONAL CONCERNS WERE IDENTIFIED FOR LOTS 0350001 AND 1070001 FOR PART CODE 1001-085-004 POTENTIALLY HAVING THE SAME CONDITION. THE PRODUCTION OF THESE LOTS OCCURRED IMMEDIATELY AFTER THE PRODUCTION OF LOT 1058001 (THE LOT WITH THE CONDITION OF MIXED PRODUCT) WITHOUT A PART CODE CHANGE OVER. THE CHANGE OVER AND LINE CLEARANCE BETWEEN THE LOTS WOULD BE BATCH CHANGE ONLY WITH A SCOPE LIMITED TO LABELS AND LOT SPECIFIC RECORDS. OTHER MATERIALS CODES WOULD NOT BE PRESENT AT THIS PRESS TO CREATE THE FAILURE MODE IDENTIFIED IN THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 300 MALE LL ADAPTORS EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 1001-085-004, BATCH/ LOT #: 1058001. SAMPLES WERE INSPECTED AND ALL IS IN COMPLIANCE. BUT IT WAS NOTICED DURING INSPECTIONS, THAT INSIDE THE BAG, IT WAS FOUND ~300 PIECES WITH A BIGGER TUBING THAT ARE OUT OF SPECIFICATION.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: AN INVALID LOT # OF 1058001 WAS PROVIDED BY THE INITIAL REPORTER 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. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 300 MALE LL ADAPTORS EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 1001-085-004. BATCH/ LOT #: 1058001. SAMPLES WERE INSPECTED AND ALL IS IN COMPLIANCE. BUT IT WAS NOTICED DURING INSPECTIONS, THAT INSIDE THE BAG, IT WAS FOUND ~300 PIECES WITH A BIGGER TUBING THAT ARE OUT OF SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639128 MALE LL ADAPTOR ADAPTOR FPA 1058001

    Patients

    Seq Age Sex Outcome Treatment
    1