BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL CHEMO 17GAL YELLOW

    MDR report key: 10188118 · Received June 24, 2020

    Report

    Report Number
    2243072-2020-00946
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    June 3, 2020
    Report Date
    July 15, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    MMK
    UDI-DI
    50382903056144
    PMA / PMN Number
    K943140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE ACTUAL PRODUCT NOR PHOTO REPRESENTATION WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED LOT WAS PERFORMED AND THERE WERE NO ISSUES FOUND FOR MISSING LIDS DURING THE MANUFACTURING PROCESS OF THE REPORTED LOT. A REVIEW OF NON-CONFORMING MATERIAL REPORT (NCMR) WAS PERFORMED FOR THE LAST TWELVE MONTHS AND DID NOT IDENTIFY ANY NONCONFORMANCE. AS CORRECTIVE ACTION A WEIGHING SYSTEM HAS ALREADY BEEN IMPLEMENTED FOR THIS CONTAINER MANUFACTURING PROCESS TO ENSURE THE CORRECT QUANTITY OF PIECES PER BOX BEFORE SHIPPING. THE ROOT CAUSE IS UNKNOWN. THE ISSUE MOST LIKELY OCCURRED DURING FULFILLMENT WHEN REPACKAGED FOR DISTRIBUTION. THIS COMPLAINT MAY HAVE OCCURRED FROM PARTIAL SALES SOLD BY A DISTRIBUTOR. ADDITIONAL INFORMATION IS NEEDED ABOUT THE HANDLING AND STORAGE BY THE DISTRIBUTOR FACILITY TO RULE OUT THAT THE ISSUE WAS NOT DUE TO INCORRECT HANDLING OR A PARTIAL SALE. BASED ON THESE FINDINGS, OUR INVESTIGATION IS INCONCLUSIVE. EVIDENCE OF ORIGINAL PACKAGING IS REQUIRED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 SHARPS COLL CHEMO 17GAL YELLOW EXPERIENCED A MISSING LID/SLIDE LID/CLAMP . PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305614 BATCH NO.: 8234808 6 COLLECTORS ARRIVED AT THE CUSTOMER WITHOUT LIDS.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: AN INVALID LOT # WAS PROVIDED AS 8234808. IF A VALID LOT # IS PROVIDED THE RECORD WILL BE UPDATED. 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. (B)(4). OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 6 SHARPS COLL CHEMO 17GAL YELLOW EXPERIENCED A MISSING LID/SLIDE LID/CLAMP. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305614 BATCH NO.: 8234808. 6 COLLECTORS ARRIVED AT THE CUSTOMER WITHOUT LIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655650 SHARPS COLL CHEMO 17GAL YELLOW SHARPS CONTAINER MMK BECTON DICKINSON UNKNOWN 50382903056144

    Patients

    Seq Age Sex Outcome Treatment
    1 Other