BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 8257227 · Received January 17, 2019

    Report

    Report Number
    9610847-2019-00004
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    December 17, 2018
    Report Date
    February 4, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903096801
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE REPORTED FAILURE MODE CANNOT BE CONFIRMED SINCE THE MARKING ON SYRINGE IS DEEMED ACCEPTABLE PER CANAAN PRINT STANDARD GUIDELINES. DHR REVIEW: COMPLAINT HISTORY CHECK FOR LOTS 8242826 & 8239986 WERE VERIFIED AND NO DISCREPANCIES WERE FOUND ABOUT THE ABOVE DESCRIBED PROBLEMS. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITIONS ON LOT NUMBERS 8242826 & 8239986. INVESTIGATION LEVEL: A REF NO PRODUCT DESC MFG CODE SUBJECT DESC 759233 CONVENIENCE SYRINGE 8242826 & 8239986 FADED GRADUATION MARKS NO FINDINGS IN QNS/NCMR/DHR ABOUT THE LOT NUMBERS 8242826 & 8239986 WERE FOUND. THIS IS CONSIDERED AS AN ISOLATED ISSUE. LOT NO #: 8242826, CATALOGUE #: 309680 QUANTITY PRODUCED: 43,220 PCS. LOT NO #: 8239986, CATALOGUE #: 309680 QUANTITY PRODUCED: 43,220 PCS. 60ML SYRINGE LOTS (P/N 8000952) USED ARE 8054983 & 8054984. NO QN¿S WERE FOUND FOR LOTS 8242826, 8239986, 8054983 & 8054984 IN SAP AND INCOMING INSPECTION RECORDS. DURING THE MANUFACTURE OF THIS PRODUCT, 100% VISUAL INSPECTION IS PERFORMED BEFORE PACKAGING THE PRODUCT IN DISPENSERS LOOKING FOR PRINTING DEFECTS ON SYRINGES. DURING THE 100% INSPECTION NO PRINTING DEFECTS ON SYRINGES WERE DETECTED BY OUR OPERATORS. THIS IS CONSIDERED AN ISOLATED ISSUE. BASED ON THE SAMPLE AND DESCRIPTION RECEIVED, THE ASSEMBLED AND MARKED SYRINGES COMING FROM COLUMBUS ARE ACCEPTABLE PER THE CANAAN PRINT STANDARD GUIDELINES SINCE THE MARKING IS LEGIBLE AND THE CHARACTERS HAVE MORE THAN 50% PRINTED AT THE NAKED EYE. PRINT DEFINITIONS: LEGIBLE-EASILY CAPABLE OF BEING READ. MISSING PRINT-MORE THAN 50% OF THE ITEM IS REMOVED OR NOT PRINTED ON THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "APPROXIMATELY 180" BD LUER-LOK¿ SYRINGES IN THE BULK STERILE PHARMACY CONVENIENCE TRAY WERE FOUND WITH "FADED GRADUATION MARKS" DURING THE FILLING PROCESS. LOT NUMBERS 8242826 AND 8239986 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY INCIDENTS OCCURRED FROM EACH LOT.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8242826. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2018-10-02. MEDICAL DEVICE LOT #: 8239986. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2018-10-02. 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 "APPROXIMATELY 180" BD LUER-LOK¿ SYRINGES IN THE BULK STERILE PHARMACY CONVENIENCE TRAY WERE FOUND WITH "FADED GRADUATION MARKS" DURING THE FILLING PROCESS. LOT NUMBERS 8242826 AND 8239986 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY INCIDENTS OCCURRED FROM EACH LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52189 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE SECTION H.10. 30382903096801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other