BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE LUER-LOK

    MDR report key: 8303155 · Received February 4, 2019

    Report

    Report Number
    1213809-2019-00151
    Event Type
    Malfunction
    Date Received
    February 4, 2019
    Date of Event
    January 18, 2019
    Report Date
    March 18, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CERTIFICATE OF COMPLIANCE WAS EVALUATED AND CONFIRMED TO HAVE THE EXPIRATION DATE OF 2023-10-31. BATCH RECORDS WERE EVALUATED AND CONFIRMED TO HAVE BLISTERS WITH BOTH DATES: 2023-10-31 AND 2023-10-23. INVESTIGATION REVEALED A CHANGE IN EXPIRATION DATE ON BLISTER PACKS DURING ONE OF THE TOP WEB CHANGES. THE EXPIRATION DATE WAS AUTOMATICALLY CORRECTED DURING PROCESS ADJUSTMENT ON THE PRINTER AT A LATER TIME. THE SCANNED SYSTEM INFORMATION RECORDS CONFIRMED ALL BARCODE INFORMATION WAS CORRECT SCANNING EXPIRATION DATE OF 2023-10-31 INCLUDING BLISTERS WITH 2023-10-23 DATE SHOWING. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. AN INCORRECT 2023-10-23 EXPIRATION DATE WAS OBSERVED ON SOME OF THE RETAINED TOP WEB SLIPS. BATCH 8316642 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. POTENTIAL ROOT CAUSE FOR THE INCORRECT EXPIRATION DATE ON THE BLISTER PACKAGES IS DUE TO HUMAN ERROR DURING ONE OF THE TOP WEB CHANGES. IT IS LIKELY THE DATE THAT IS PRINTED ON THE PACKAGE WAS MANUALLY ENTERED BY AN OPERATOR WITH A TYPO DURING ENTRY. THIS HUMAN ERROR WAS LIKELY UNINTENTIONAL. THE CERTIFICATE OF COMPLIANCE DATE OF 2023-10-31 IS CORRECT. SINCE THE 2023-10-23 DATED PACKAGES ARE SHOWING 8 DAYS SHORTER EXPIRATION THAN WAS INTENDED, THE PRODUCT IS CONSIDERED SAFE TO USE BECAUSE THE 2023-10-23 DATE IS WITHIN THE PRODUCT¿S SHELF LIFE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE LUER-LOK¿ HAD INCORRECT LABEL INFORMATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK SYRINGE LUER-LOK HAD INCORRECT LABEL INFORMATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94589 BD PLASTIPAK SYRINGE LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8316642 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other