BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1 ML SYRINGE LUER SLIP TIP CONVENIENCE PAK

    MDR report key: 10962197 · Received December 7, 2020

    Report

    Report Number
    9610847-2020-00397
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    October 29, 2020
    Report Date
    February 18, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903097012
    PMA / PMN Number
    K980580
    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 DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED FINAL LOT NUMBER 0092223 AND ALL APPLICABLE SUB-ASSEMBLY LOT NUMBERS. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, THE BARREL CAVITY OF THE SYRINGE WAS OBSERVED DAMAGED. THE DAMAGES APPEARED TO BE ELONGATED AND INDENTED. IT HAS BEEN DETERMINED THAT THE DAMAGED BARRELS MOST LIKELY RESULTED DURING THE BD ASSEMBLY PROCESS; HOWEVER, AND EXACT POINT OF ERROR HAS NOT BEEN IDENTIFIED. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 25 BD 1 ML SYRINGE LUER SLIP TIP CONVENIENCE PAKS EXPERIENCED MOLDING DEFECTS -SHORT SHOTS ON BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309701 BATCH NO: 0092223 I'M REACHING OUT IN REGARDS TO WHAT APPEARS TO BE A MOLDING ISSUE WITH OUR 1ML SLIP TIP SYRINGE'S. THIS PARTICULAR ISSUE IS FOUND IN THE 25 COUNT TRAYS THAT WE ORDER. THE DEFECT APPEARS TO BE A SMALL INDENTATION AND IS ABOUT 0.5 CM IN LENGTH, IT IS THE SAME SIZE AND SHAPE ON EVERY AFFECTED SYRINGE THAT WE ENCOUNTER LEADING US TO BELIEVE IT COULD BE AN ERROR WITH THE MOLDING.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 25 BD 1 ML SYRINGE LUER SLIP TIP CONVENIENCE PAKS EXPERIENCED MOLDING DEFECTS SHORT SHOTS ON BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309701, BATCH NO: 0092223. I'M REACHING OUT IN REGARDS TO WHAT APPEARS TO BE A MOLDING ISSUE WITH OUR 1ML SLIP TIP SYRINGE'S. THIS PARTICULAR ISSUE IS FOUND IN THE 25 COUNT TRAYS THAT WE ORDER. THE DEFECT APPEARS TO BE A SMALL INDENTATION AND IS ABOUT 0.5 CM IN LENGTH, IT IS THE SAME SIZE AND SHAPE ON EVERY AFFECTED SYRINGE THAT WE ENCOUNTER LEADING US TO BELIEVE IT COULD BE AN ERROR WITH THE MOLDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426863 BD 1 ML SYRINGE LUER SLIP TIP CONVENIENCE PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0092223 00382903097012

    Patients

    Seq Age Sex Outcome Treatment
    1