BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 10209962 · Received June 29, 2020

    Report

    Report Number
    3003152976-2020-00278
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    June 15, 2020
    Report Date
    June 18, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: THREE PHOTOS WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE PHOTOS, DAMAGE WAS OBSERVED NEAR THE 32ML SCALE MARKING ON THE BARREL, RESULTING IN A LEAK WHEN THE STOPPER MOVES ACROSS THIS POINT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2003287, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCT S IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THE DAMAGE WAS LIKELY CAUSED AS A RESULT OF A FAILURE WITHIN THE MANUFACTURING EQUIPMENT DURING ASSEMBLY. A PROJECT HAS BEEN INITIATED TO FURTHER INVESTIGATE AND REDUCE DAMAGE ON OUR PRODUCTS. WE HAVE NOTIFIED MANUFACTURING PERSONNEL OF YOUR EXPERIENCE TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. INVESTIGATION CONCLUSION: UPON VISUAL INSPECTION OF THIS PICTURES RECEIVED, IT CAN BE OBSERVED THE BARREL OF THE SYRINGE HAS A DAMAGE, IT WAS CRACKED (AT THE 32ML, ON THE SCALE MARKING). THIS DAMAGE IS THE CAUSE OF THE LEAKAGE BECAUSE WHEN STOPPER IS MOVED FORWARD AT THIS POINT, IT RESULTED JAMMED AGAINST BARREL WALLS CAUSING LEAKAGE. DHR OF LOT 2003287 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. ROOT CAUSE DESCRIPTION: FAILURE IN ASSEMBLY MACHINE DURING MANUFACTURING PROCESS. RATIONALE: CORRECTIVE ACTION (B)(4) IS OPEN TO INVESTIGATE AND REDUCE DAMAGE ON 50LL PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE LEAKED DURING USE WHILE INJECTING "5-FLUOROURACIL", AND A CRACK WAS FOUND IN THE BARREL AT THE "32ML" MARKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "WHEN INJECTING 5-FLUOROURACIL INTO A PORTABLE DISPENSER WITH A 50 ML SYRINGE, THE PREPARER NOTICED A LEAKAGE. WHILE OBSERVING HER SYRINGE, SHE NOTICED THAT IT WAS CRACKED (AT THE 32ML, ON THE SCALE MARKING). SHE HAD TO USE ANOTHER SYRINGE TO FINISH HER PREPARATION AND TRIED TO REMOVE THE 5-FU FROM THE DEFECTIVE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674253 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2003287

    Patients

    Seq Age Sex Outcome Treatment
    1 Other