BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL W/NDL SFTYGLD 22X1-1/2 RB

    MDR report key: 10222540 · Received July 2, 2020

    Report

    Report Number
    9610847-2020-00197
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Date of Event
    June 11, 2020
    Report Date
    August 24, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903059073
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVALUATION? YES. D.10 RETURNED TO MANUFACTURER ON: (B)(6) 2020. H.6. INVESTIGATION SUMMARY AS A LOT NUMBER WAS UNKNOWN FOR THIS INCIDENT, A REVIEW OF THE PRODUCTION HISTORY COULD NOT BE COMPLETED FOR THIS SPECIFIC PRODUCT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE OPENED SAMPLE, THE STOPPER WAS FOUND TO BE DISTORTED WITHIN THE SYRINGE. BASED ON THE INVESTIGATION RESULTS, AN EXACT MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 5ML LL W/NDL SFTYGLD 22X1-1/2 RB EXPERIENCED A MISALIGNED/JAMMED/INSECURE STOPPER AND STOPPER DAMAGE/DEFORMATION. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONGESTION DEFORMATION

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. PMA/510(K)#: AN ADDITIONAL PMA/510(K)# IS LISTED FOR THIS DEVICE AS K951254. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 5ML LL W/NDL SFTYGLD 22X1-1/2 RB EXPERIENCED A MISALIGNED/JAMMED/INSECURE STOPPER AND STOPPER DAMAGE/DEFORMATION. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONGESTION DEFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686435 SYRINGE 5ML LL W/NDL SFTYGLD 22X1-1/2 RB SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 305907 UNKNOWN 30382903059073

    Patients

    Seq Age Sex Outcome Treatment
    1 Other