BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 12624681 · Received October 13, 2021

    Report

    Report Number
    1911916-2021-01069
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    September 15, 2021
    Report Date
    November 5, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: 2021-10-29. H6: INVESTIGATION SUMMARY IT WAS REPORTED THAT THE STERILITY WAS COMPROMISED. TO AID IN THE INVESTIGATION, TWO SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE SAMPLE CAME WITH NO PACKAGING BLISTER AND A NEEDLE ASSEMBLY ATTACHED. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PLUNGER ROD-RUBBER STOPPER WAS PUSHED TO THE BOTTOM OF THE SYRINGE AND THE LUBRICANT WAS VISIBLE; THIS IS NORMAL. THE OTHER SAMPLE CAME IN A SEALED PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. JUST AS WITH THE OTHER SAMPLE, THE LUBRICANT IS MADE VISIBLE BE PRESSING THE PLUNGER ROD-RUBBER STOPPER TOWARDS THE BOTTOM OF THE SYRINGE BARREL. THE LUBRICANT IS MEDICAL GRADE AND IS APPLIED TO THE RUBBER STOPPER AND INNER WALL OF THE SYRINGE BARREL TO MAKE THE MOVEMENT OF THE PLUNGER ROD-RUBBER STOPPER SMOOTH. IT COULD BE THE CUSTOMER IS CONFUSED BY THE PRESENCE OF THE LUBRICANT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBER 1091300. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP SYRINGE PACKAGING SEAL WAS COMPROMISED, ALLOWING OIL TO ENTER THE BARREL AND PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STERILITY COMPROMISED / SEAL INTEGRITY VERBATIM: OIL ENDS UP IN THE SYRINGE AND THE PLUNGER, IS NOT STERILE."

    Additional Manufacturer Narrative · 1

    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 THE BD LUER-LOK¿ TIP SYRINGE PACKAGING SEAL WAS COMPROMISED, ALLOWING OIL TO ENTER THE BARREL AND PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STERILITY COMPROMISED / SEAL INTEGRITY VERBATIM: OIL ENDS UP IN THE SYRINGE AND THE PLUNGER, IS NOT STERILE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521742 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302830 1091300 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown