BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE

    MDR report key: 16482720 · Received March 3, 2023

    Report

    Report Number
    1213809-2023-00146
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    January 16, 2023
    Report Date
    March 13, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096589
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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: 27-FEB-2023. H6: INVESTIGATION SUMMARY: SEVENTY-FOUR SAMPLES AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED ON RECEIVED SAMPLES. UPON EXAMINATION OF THE RETURNED PHOTOS, IT WAS OBSERVED THAT SOME EXCESSIVE AMOUNT OF TRANSPARENT LIQUID ACCUMULATED ON TOP OF THE STOPPER INSIDE THE SYRINGE. BASED ON THE PHOTOS THE AMOUNT OF OBSERVED SILICONE WAS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE EXCESS SILICONE DEFECTS IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE DEFECTS ARE OCCURRING BELOW AN EXPECTED RATE SO NO CORRECTIVE ACTIONS WILL BE MADE AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2221955. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT A VISCOUS, TRANSPARENT LIQUID WAS OBSERVED ON THE PLUNGER OF THE BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "THERE IS LIQUID INSIDE THE SYRINGE IN SEVERAL SYRINGES OF THIS BATCH, ESPECIALLY ON THE PLUNGER. IT IS A TRANSPARENT AND VISCOUS LIQUID THAT DRAWS THREADS WHEN THE PLUNGER IS MOVED...WITH THE NEW BATCH, WE ALSO NOTICED THAT THERE IS LIQUID INSIDE THE TIPS OF SEVERAL SYRINGES. ESPECIALLY ON THE PLUNGER, YOU CAN OBSERVE A VISCOUS, TRANSPARENT LIQUID THAT PULLS THREADS WHEN YOU MOVE THE PLUNGER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VISCOUS, TRANSPARENT LIQUID WAS OBSERVED ON THE PLUNGER OF THE BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "THERE IS LIQUID INSIDE THE SYRINGE IN SEVERAL SYRINGES OF THIS BATCH, ESPECIALLY ON THE PLUNGER. IT IS A TRANSPARENT AND VISCOUS LIQUID THAT DRAWS THREADS WHEN THE PLUNGER IS MOVED... WITH THE NEW BATCH, WE ALSO NOTICED THAT THERE IS LIQUID INSIDE THE TIPS OF SEVERAL SYRINGES. ESPECIALLY ON THE PLUNGER, YOU CAN OBSERVE A VISCOUS, TRANSPARENT LIQUID THAT PULLS THREADS WHEN YOU MOVE THE PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826181 BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2221955 00382903096589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown