BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 12346327 · Received August 19, 2021

    Report

    Report Number
    3003152976-2021-00487
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 21, 2021
    Report Date
    September 24, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-08-16. H6: INVESTIGATION SUMMARY: SAMPLE AND PHOTOS RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION OF THE SAMPLE IT CAN BE SEEN FOREIGN MATTER INSIDE THE BLISTER. THE FOREIGN MATTER FOUND IS A PIECE OF FILM FROM UNITARY PACKAGING STAINED WITH GREASE, THE BLACK GREASE ALSO STAINED THE PAPER FROM THE UNITARY PACKAGING. ONCE EXAMINED, THE FOREIGN MATTER ATTACHED TO THE BARREL CAN BE CONFIRMED TO BE PLASTIC FROM THE BAG WHERE BULK PRODUCT IS PACKAGED. THIS DEFECT CAN BE PRODUCED IN PRIMARY PACKAGING PROCESS IF FILM GETS STUCK IN THE CHAINS OF THE EQUIPMENT THAT LOCATES THE PRODUCT ALONG THE PROCESS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2010002, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION AND THERE IS NO DAMAGE ON THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE BLISTER PACK WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "THE SYRINGE WAS TAKEN OUT OF THE BLISTER FOR THE PREPARATION OF CYTOSTATICS AND NOURISHMENT FOR INFANTS, NO CONTAMINATION OCCURRED. IT WAS NOTICED THAT THE BLISTER IS DIRTY ON THE OUTSIDE AND IN THE INSIDE."

    Additional Manufacturer Narrative · 1

    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 THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE BLISTER PACK WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE SYRINGE WAS TAKEN OUT OF THE BLISTER FOR THE PREPARATION OF CYTOSTATICS AND NOURISHMENT FOR INFANTS, NO CONTAMINATION OCCURRED. IT WAS NOTICED THAT THE BLISTER IS DIRTY ON THE OUTSIDE AND IN THE INSIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242929 BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2010002

    Patients

    Seq Age Sex Outcome Treatment
    1