BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER LOK 3 ML SYRINGE BULK CONVENIENCE PAK

    MDR report key: 11492595 · Received March 16, 2021

    Report

    Report Number
    9610847-2021-00099
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 17, 2021
    Report Date
    March 25, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A COMPLAINT OF FOREIGN MATTER IN A SYRINGE WAS RECEIVED FROM THE CUSTOMER. A PHOTO WAS PROVIDED TO AID IN THE INVESTIGATION OF THIS DEFECT. FOREIGN MATTER WAS OBSERVED IN THE SOLUTION INSIDE THE SYRINGE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 9213438. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. A ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE SYRINGE WAS ALREADY IN USE. THIS IS THE FIRST COMPLAINT FOR FOREIGN MATTER ON MATERIAL 309702 & BATCH 9213438.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER LOK¿ 3 ML SYRINGE BULK CONVENIENCE PAK EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA/NEEDLE/CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:309702, BATCH NO: 9213438. I WANTED TO REPORT AN ISSUE WITH ONE OF THE 3 ML SYRINGES IN THE BULK STERILE CONVENIENCE PAK LOT 9213438 EXP 4/30/24. THERE APPEARS TO BE SOMETHING ON THE INSIDE OF THE SYRINGE BY THE ½ ML MARKING THAT IS ADHERED TO THE SIDE OR WITHIN THE PLASTIC ITSELF.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER ADDR 1: (B)(6). 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¿ 3 ML SYRINGE BULK CONVENIENCE PAK EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA/NEEDLE/CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:309702, BATCH NO: 9213438. I WANTED TO REPORT AN ISSUE WITH ONE OF THE 3 ML SYRINGES IN THE BULK STERILE CONVENIENCE PAK LOT 9213438 EXP 4/30/24. THERE APPEARS TO BE SOMETHING ON THE INSIDE OF THE SYRINGE BY THE ½ ML MARKING THAT IS ADHERED TO THE SIDE OR WITHIN THE PLASTIC ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390736 BD LUER LOK 3 ML SYRINGE BULK CONVENIENCE PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9213438

    Patients

    Seq Age Sex Outcome Treatment
    1