BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 8723089 · Received June 21, 2019

    Report

    Report Number
    9610847-2019-00426
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    April 11, 2019
    Report Date
    June 3, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE RECEIVED; THEREFORE, SAMPLE ANALYSIS COULD NOT BE PERFORMED AND THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WITHOUT A SAMPLE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, LEAKAGE CAN BE CAUSED BY THE INTERACTION BETWEEN THE BARREL INSIDE DIAMETER, THE STOPPER OUTSIDE DIAMETER, AND PLUNGER ROD BAYONET OUTSIDE DIAMETER AND FORCES APPLIED DURING USE. THE SYRINGE IS MORE LIKELY TO LEAK WHEN FORCES ARE APPLIED TO THE PLUNGER ROD WHEN FULLY EXTENDED. A CAPA (CORRECTIVE ACTION PREVENTIVE ACTION) HAS BEEN INITIATED TO INVESTIGATE THIS ISSUE FURTHER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LEAKAGE PAST STOPPER FOR LOT #9021501 ITEM #309680. RELATED COMPLAINT: (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE COLUMBUS BATCHES ASSOCIATED WITH THE (B)(4) BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. ROOT CAUSE DESCRIPTION: LEAKAGE CAN BE CAUSED BY THE INTERACTION BETWEEN THE BARREL INSIDE DIAMETER, THE STOPPER OUTSIDE DIAMETER, AND PLUNGER ROD BAYONET OUTSIDE DIAMETER AND FORCES APPLIED DURING USE. THE SYRINGE IS MORE LIKELY TO LEAK WHEN FORCES ARE APPLIED TO THE PLUNGER ROD WHEN FULLY EXTENDED. RATIONALE: BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. HOWEVER, BD HAS EXPERIENCED SIMILAR COMPLAINTS IN THE PAST AND THE FOLLOWING CORRECTIVE AND/OR PREVENTATIVE ACTION (CAPA) HAS BEEN IMPLEMENTED. CAPA (B)(4)¿ 60ML LEAKAGE PAST STOPPER IS CURRENTLY UNDERWAY TO REDUCE THESE COMPLAINTS AND BECAUSE A DV WAS NOT COMPLETED WHEN BD ORIGINALLY WENT FROM 50ML TO 60ML. THIS CAPA INVOLVES GOING FROM 60ML TO 50ML BECAUSE IT WILL INCREASE THE STABILITY OF THE PLUNGER ROD. THE SPEC DEVIATION SD 2017-017 IS CURRENTLY ALLOWING 60ML PRODUCT TO BE SOLD, WHILE ALSO KNOWING THAT 60ML PRODUCT HAS INCREASED LEAKAGE PAST THE STOPPER. THE CAPA AND VALIDATION/VERIFICATION FOR THIS IS EXPECTED TO BE COMPLETED BY THE END OF THIS YEAR. AFTER WHICH, A SHELF LIFE STUDY WILL CONFIRM THAT THE PRODUCT MEETS THE LEAKAGE PAST STOPPER REQUIREMENT OVER 5 YEARS SHELF LIFE.

    Description of Event or Problem · 1

    MATERIAL NO: 309680, BATCH NO: 9021501. IT WAS REPORTED THAT DURING USE OF THE BD LUER-LOK¿ SYRINGE THE CONTENTS LEAKED ONTO THE PATIENT BY THE PISTON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE FAILED TO FUNCTION AND THE CONTENTS LEAKED ONTO THE PATIENT BY THE PISTON. PRODUCT INSIDE WAS 5-FU CHEMOTHERAPY MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516352 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9021501 30382903096801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other