BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL 17GAL RED

    MDR report key: 10196825 · Received June 25, 2020

    Report

    Report Number
    2243072-2020-00966
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Date of Event
    June 5, 2020
    Report Date
    August 5, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903056106
    PMA / PMN Number
    K943575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 AN UNSPECIFIED NUMBER OF SHARPS COLL 17GAL RED EXPERIENCED THE LID OR SLIDE LID/CLAMP MISSING. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305610 BATCH NO: 0044914 CUSTOMER SAYS ONE OF THE CASES IS MISSING ALL THE LIDS. WOULD LIKE THE LIDS SENT OUT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (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 AN UNSPECIFIED NUMBER OF SHARPS COLL 17GAL RED EXPERIENCED THE LID OR SLIDE LID/CLAMP MISSING. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305610 BATCH NO: 0044914. CUSTOMER SAYS ONE OF THE CASES IS MISSING ALL THE LIDS. WOULD LIKE THE LIDS SENT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657558 SHARPS COLL 17GAL RED HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 0044914 50382903056106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other